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S-ROM® NOILES™

ROTATING HINGE

SURGICAL TECHNIQUE

2 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

TABLE OF CONTENTS

SURGICAL TECHNIQUE Key Surgical Steps Summary 4

S-ROM® Noiles™ Rotating Hinge Knee System 6

The S-ROM Hinge System Overview 7

Incision and Exposure 8

Intra-operative Evaluation 10

Initial Preparation of the Tibia 11

Preparation of the Metaphyseal Bone 13

– Tapered Reamer

Proximal Tibial Resection – Tapered Reamer 14

Preparation of the Metaphyseal Bone – Broach 16

Tibial Trial Assembly 18

Preparation of Femoral Diaphysis 19

Reaming the Medullary Canal 20

Preparation of the Metaphysis – Sleeve Use 22

Femoral Preparation – Distal Resection 26

Femoral A/P and Chamfer Cuts 29

Femoral Box Cuts 31

Final Preparation of the Tibia 32

Femoral Trial Insertion 33

Trial Reduction 36

Implant Assembly – Tibia 37

Tibial Implantation 38

Implant Assembly – Sleeve and Stem Use 39

Bearing and Hinge Pin Insertion 42

Initial Patellar Resection 43

Patella Reaming 45

Patella Drilling 46

Trial Reduction and Implantation 47

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 3

APPENDICES

ORDERING INFORMATION

Appendix 1: The Cemented Tibial Stem Extensions 48

Appendix 2: Step Wedge Preparation 51

Appendix 3: Thick Tray Preparation 54

Implant Listing 55

Compatibility Chart 59

Instruments 60

KEY SURGICAL STEPS SUMMARY

Patella Preparation

Final Trialing

Distal Femoral Resection

Femoral Medullary Canal Preparation

Tibial Medullary Canal PreparationIncision and Exposure

4 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Implantation

Femoral Preparation -

A/P and Chamfer Cuts Femoral Box Cuts

Tibial Resection Tibial Trial Assembly

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 5

S-ROM® NOILES™ ROTATING HINGE KNEE SYSTEM

The S-ROM NOILES Rotating Hinge features:

· S-ROM Femoral Components available in three sizes

· 7 degree physiological valgus, fixed in the femoral

component

· Deep femoral trochlear groove

· Modular porous sleeves to accommodate bone defects

of the Engh Type II

and Type III classification and allow possible bone

ingrowth

· Available with both cemented and press-fit slotted

stems for both femur

and tibia

· Broad, congruent contact areas between femoral and

tibial components

to best distribute surface and sub-surface stresses in

the polyethylene

· A rotating hinge that accommodates axial rotation,

reducing stresses at

the bone cement/implant interfaces

6 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

THE S-ROM HINGE SYSTEM OVERVIEW

The MBT Revision Knee System is comprised

of the following components:

· Tibial Components are available in eight sizes,

1, 1.5, 2, 2.5, 3, 4, 5 and 6

· Tibial Metaphyseal Sleeves are available in 29 mm

(cemented or porous), 37 mm, 45 mm, 53 mm and

61 mm sizes (M/L dimension)

· Tibial Wedge Augmentation Components:

Step Wedge in 5, 10 and 15 mm thicknesses

· 75, 115 and 150 mm Fluted Universal Stem lengths

in 10 to 24 mm diameters in 2 mm increments

· 30 and 60 mm Cemented Universal Stem lengths in

13 mm diameters. 90, 120, 150 Cemented Tapered

Universal stem lengths in 13 mm diameters

· Thick Trays are available in three different sizes

(2, 3 and 4) and two different thicknesses

(+15 mm and +25 mm)

· Accepts Rotating Platform hinged insert from the LPS™

(Limb Preservation System), which is compatible with

the S-ROM NOILES Rotating Hinge (NRH) Femoral

Component and LPS Femoral Component

The S-ROM Hinge Knee System is comprised

of the following components:

· Hinged Femoral Component is available in three sizes,

X-Small, Small and Medium

· Femoral Metaphyseal Sleeves are available in 20 mm

(cemented only), 31 mm, 34 mm, 40 mm and 46 mm

sizes (M/L dimension), and can be used with or

without a stem

· 5 and 10 mm Distal Femoral Augments

· 75 mm, 115 mm and 150 mm Fluted Universal Stem

lengths in 10 mm to 24 mm diameters in 2 mm

increments

· 30 mm and 60 mm Cemented Universal Stem Lengths

in 13 mm and 15 mm diameters

· 90 mm, 120 mm, and 150 mm Tapered Cemented

Universal Stem lengths in a 13 mm diameter

· 90 mm Tapered Cemented Universal Stem length in a

15 mm diameter (Must be used with a sleeve)

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 7

INCISION AND EXPOSURE

Initial Incision

When possible, follow the scar from the primary

procedure (Figure 1). Where parallel incisions are

present, the more lateral is usually preferred, as the

blood supply to the extensor surface is medially

dominant. Where a transverse patellectomy scar is

present, the incision should transect it at 90 degrees.

Where there are multiple incision scars or substantial

cutaneous damage (burn cases, skin grafting, etc.), one

may wish to consult a plastic surgeon prior to surgery to

design the incision, determine the efficacy of

pre-operative soft tissue expansion and plan for

appropriate soft tissue coverage at closure.

Capsular Incision

The fascial incision extends from the rectus femoris

proximal margin to the distal margin of the tibial

tubercle following the patella’s medial border,

maintaining a 3-4 mm cuff for reapproximation of the

vastus medialis aponeurosis at closure (Figure 2). Where

mobilization of the extensor mechanism and patella is

problematic, extend the skin and capsular incisions

proximally.

Figure 2

Figure 1

8 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

INCISION AND EXPOSURE

Occasionally an early retinacular release is indicated to

assist with patellar eversion. Where eversion difficulties

persist, a quadriceps snip, a proximal inverted quadriceps

incision (modified V-Y) or a tibial-tubercle osteotomy

may be indicated. Perform appropriate ligamentous

release based upon pre-operative and intra-operative

evaluation. Release fibrous adhesions to re-establish the

suprapatellar pouch and medial and lateral gutters

(Figure 3). In many revision cases, the posterior cruciate

ligament will be absent or non-functional; when this is

the situation, excise any residual portion. Exercise care

when everting the patella. Frequently, subluxing the

patella laterally is adequate. Doing so will help avoid

patella tendon avulsion.

Implant Extraction from the Primary Procedure

Take care to preserve as much bone as possible. To this

end, assemble a selection of tools, including thin

Osteotomes, an Oscillating Saw, a Gigli Saw, a

highspeed Burr and various extraction devices, but many

cases will require only the thin Osteotome. Carefully

disrupt the bone/cement or bone prosthesis interface

before attempting extraction (Figure 4).

Disengage the implanted components and extract as

gently as possible, in such manner as to avoid fracture

and unnecessary sacrifice of bone stock. Where the

entire prosthesis is to be replaced, it is advantageous to

remove the femoral component first, as this will enhance

access to the proximal tibia. Clear all residual methyl

methacrylate with hand (chisels) or power tools.

Figure 3

Figure 4

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 9

INTRA-OPERATIVE EVALUATION

The surgeon should establish two anatomic conditions

to facilitate revision arthroplasty: the level of the joint

line and the disparity in the flexion and extension gaps

(Figure 5).

Joint Line Evaluation

In an average knee in full extension, the true joint line

can be approximated in reference to several landmarks.

· It lies 12–16 mm distal to the femoral PCL

attachment

· It lies approximately 3 cm distal to the medial

epicondyle and 2.5 cm distal to the lateral

epicondyle

· It lies distal to the inferior pole of the patella

(approximately one finger width)

· Level with the old meniscal scar, if available

Additional pre-operative joint line assessment

tools include:

1) Review of original pre-operative roentgenogram

of the Total Knee Arthroplasty (TKA)

2) Review of roentgenogram of contralateral knee

if non-implanted

Figure 5

10 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Figure 6

INITIAL PREPARATION OF THE TIBIA

The Tibial Alignment System

When pre-operative evaluation and X-rays indicate that

Fluted Stem Extensions, Metaphyseal Sleeves or Wedges

are required, it is recommended that the proximal tibia be

prepared with reference to the position of the I.M. Rod.

Note: Where a Cemented Stem Extension is

indicated, see Appendix 1 (page 48).

Place the knee in maximal flexion with the patella

laterally retracted and the tibia distracted anteriorly and

stabilized. Release fibrosis around the tibial border or

excise as required to ensure complete visualization of its

periphery.

Approximate the location of the medullary canal with

reference to pre-operative anterior/posterior (A/P) and

lateral X-rays and to the medial third of the tibial

tubercle.

Introduce a 9 mm drill into the canal to a depth of

2–4 cm. Avoid cortical contact (Figure 6).

4 cm

2 cm

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 11

Reaming the Medullary Canal

Assemble the Straight Reamer to the T-Handle. If power

reaming, it will be necessary to attach the modified

Hudson Adapter to the Straight Reamer. The shaft of the

reamer contains markings in 25.4 mm (1 in) increments.

Each marking is numbered to use as a reference when

reaming to the appropriate depth. Fluted stem lengths

are available in 75, 115 and 150 mm. Determine the

length and diameter of the prosthetic Stem Extension

with Templates (Cat. No. 2178-30-100) applied to pre-

operative X-rays.

Use the Reamer Depth Chart (Figure 7) to determine the

appropriate mark on the reamer for canal reaming

depth. Another option to determine reamer depth is to

measure the trial assembly against the reamer and note

the corresponding depth mark for reaming. Sequentially

open the canal with progressively larger reamers until

firm endosteal engagement is established (Figure 8).

Note: Simple cortical contact should not be

construed as engagement.

The fixed relationship of the reamer to the cortices

ensures the secure fit of the appropriate reamer and,

subsequently, the corresponding fluted stem. It is equally

important to not over-ream osteopenic bone. While

reaming the proximal tibia, pay close attention to the

reamer to assure that it is somewhat centrally located to

the exposed proximal tibial surface. Eccentric reaming

can occur, which could lead to undersizing of the tibial

component.

The size of the final reamer indicates the diameter

of the implant stem. The fluted stems are available in

even sizes (10 through 24 mm). Perform final reaming

with an even-sized reamer. The final implant will have a

.4 mm press-fit versus the reamer and a .5 mm press- fit

versus the Stem Trials.

Note: Refer to Appendix 1 (page 48) for cemented

stem preparation.

T-Handle

Straight

Reamer

INITIAL PREPARATION OF THE TIBIA

Figure 7

Figure 8

MBT Revision Tray Reamer Line Depth

Press-Fit

Stems

75 mm 2

115 mm 3

150 mm 4

Cemented

Stems

30 mm 1

60 mm 2

90 mm 2.5

120 mm 3.5

150 mm 4

12 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Tibial

Resection

Plane Notches on the Drill

PREPARATION OF THE METAPHYSEAL BONE

– TAPERED REAMER

For Diaphyseal Engaging Stem and

Metaphyseal Filling Sleeve

Attach the appropriately sized Stem Trial to the end of

the MBT Revision Tapered Reamer.

Note: Assembly of the Stem Trial may be aided

by the pre-attachment of the T-Handle to the MBT

Revision Tapered Reamer.

Taper ream to the planned proximal tibial resection level

(Figure 9). When finished reaming, the notches on the

Drill should line up with the planned proximal tibial

resection level.

Note: Use the “cemented” Tapered Reamer when

requiring a cement mantle or when utilizing a

sleeve. Use the Press-Fit Tapered Reamer when

line-to-line fit is desired and a sleeve will not be

utilized (Figure 10). Use End-Cutting Primary

Reamer (Cat. No. 2178-63-199) when a stem or

sleeve will not be used.

Note: To avoid Stem Trial disengagement, do not

reverse ream.

At this point, intra-operatively determine if a

Metaphyseal Sleeve will be used.

Note: Metaphyseal Sleeves are ideal to provide

filling of Engh Type II or III defects in revision

TKA. The steps of the Metaphyseal Sleeve also

provide progressive loading of the bone with porous

coating, which enhances fixation.

If a Metaphyseal Sleeve is selected, see page 16 in order

to broach the metaphyseal bone.

If a Metaphyseal Sleeve will not be used, see the

following page to prepare for the proximal tibial

resection.

Figure 9

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 13

PROXIMAL TIBIAL RESECTION – TAPERED REAMER

Attach the 2 degree Tibial Cutting Block to the I.M.

Tibial Referencing Device. Attach the I.M. Tibial

Referencing Device to the shaft of the Tapered Reamer.

Position the I.M. Tibial Referencing Device with the pre-

attached 2 degree Cutting Block onto the shaft and

allow it to descend to the proximal tibial surface. Since

considerable bone stock may have been sacrificed in the

primary TKA, minimize the amount resected: no more

than 1-2 mm from the most prominent condyle,

managing residual defects of the contralateral condyle

with either prosthetic augment or bone graft.

Resection is based on tibial deficiency and the level of

the joint line. Compensate deficiencies with sleeves,

wedges and/or bone grafts. Advance the cutting block

to the anterior tibial cortex and lock into position by

tightening the knurled knob on the outrigger.

Preliminary rotational alignment is based on the medial

third of the tibial tubercle. Secure the alignment device

to the reamer shaft with the lateral Setscrew (Figure 10).

Pin the Tibial Cutting Block so a minimal resection is

made from the proximal tibia. Utilize the Stylus when

necessary (Figure 10).

Note: There is a slotted and non-slotted end to the

Stylus. The difference between the two is

5 mm.

Note: If a Metaphyseal Sleeve is to be used the tibial

resection will be performed using the Tibial Sleeve

Broach (see page 16, Figure 12).

Figure 10

Pins

14 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

PROXIMAL TIBIAL RESECTION – TAPERED REAMER

Remove the I.M. device while leaving the degree Cutting

Block in place. Remove the Tapered Reamer and resect

the proximal tibia (Figure 11).

Note: At this point determine whether a step wedge

is necessary on either the medial or lateral side to

augment a defect, or both sides in order to restore

the joint line. If a wedge is necessary on one side,

it is recommended that the step wedge be prepared

after rotational position of both the femoral and

tibial components have been determined. For step

wedge preparation see Appendix 2 (page 51).

Figure 11

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 15

PREPARATION OF THE METAPHYSEAL BONE – BROACH

Optional For Sleeve Utilization Only

Note: The MBT Revision Tibial Tray will accept

either a tibial Metaphyseal Sleeve or a tibial Step

Wedge. Only the 29 mm Sleeve is indicated for use

with a Tibial Step Wedge.

Attach the MBT Revision Broach Handle to the smallest

broach and then attach the appropriately sized Stem

Trial. The broaches are asymmetrical, position the “ANT”

engraving on the broach anteriorly. Impact the broach

into the tibia until the top surface of the broach is at the

desired proximal tibial resection level. When broaching

the proximal metaphysis, take care to assure the

appropriate rotation of the Broach.

Note: The corresponding tibial sleeve implant

allows up to +/- 20 degrees of rotation from

the centerline of the MBT Revision Tray.

Check for rotational stability of the broach. If the broach

(not the handle) moves in the canal, it is not rotationally

stable.

If the broach is unstable or the defect is unfilled, repeat

with consecutively larger broaches until the desired fit is

achieved (Figure 12). Remove the Broach Handle, leaving

the last broach in place. Any defects remaining can be

filled with allograft or autologous bone placed in

intimate contact with the sleeve.

Two common tibial broaching techniques:

1) Chase the defect by rotating the broach to fill the

defect until reaching rotational stability of the broach.

If utilizing this technique the surgeon must be aware

that the sleeves are allowed to rotate +/-20 degrees

with respect to the MBT Revision Tibial Tray.

2) Align the broach with the medial third of the tibial

tubercle and progressively broach until rotational

stability of the broach is attained.

Figure 12

Tibial

Resection

Plane

16 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

PREPARATION OF THE METAPHYSEAL BONE – BROACH

Resect the proximal tibia utilizing the top of the broach

as a guide (Figure 13). The top of the broach has a 2

degree slope built in. The proximal cut should be parallel

to the top of the broach.

Note: If a cutting guide is desired for resecting

the proximal tibia with the tibial broach in place,

assemble the SP2 0 degree Tibial Cutting Block

(Cat. No. 96-6320) to the SP2 IM Tibial Guide and

slide over the Broach Adapter Outrigger (Cat. No.

2178-01-108). Slide this assembly onto the boss of

the seated tibial broach, pin the block, remove the

outrigger, and resect through the slot of the cutting

block (Figure 14).

Slide the tibial view plate which best covers the proximal

tibial over the broach post. Note the view plate size as it

will dictate the size of the MBT Revision Tibial Base Trial

that will be used. The tibial view plate is transparent to

help visualize tibial coverage (Figure 15). The template

matches the implant to aid in orienting the tibial sleeve

to the tibial base during assembly.

Figure 15

Figure 14

Figure 13

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 17

TIBIAL TRIAL ASSEMBLY

Assemble the tibial tray trial with the stem extension and

sleeve trial, if applicable (Figure 16). Position the Tibial

Trial construct into the prepared tibial canal (Figure 17).

Assess proximal tibial coverage and rotation of tibial

component. The base plate should be positioned to

provide the best coverage of the tibial condylar surface.

Note: The MBT Revision Tibial Keel Punch with the

Universal Handle may be utilized to assist with seating of

tibial trial construct. Once the tibial trial construct is

seated the Keel Punch must be removed in order to

accommodate the use of Spacer Blocks.

Leave the trial in place and proceed to femoral

preparation, final tibial preparation will occur after

femoral preparation is complete.

Note: A 14 mm or smaller size stem implant can be

pulled through the sleeve implant. If the stem is 16

mm or greater it will not pull through the sleeve.

Figure 16

Figure 17

18 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

PREPARATION OF FEMORAL DIAPHYSIS

Figure 18

Intramedullary Femoral Alignment System

This technique is designed to flow in a logical sequence,

from reaming the diaphysis, to broaching the

metaphysis and cutting the bone. The length and

diameter of the stem extension is determined with

templates applied to pre-operative roentgenograms.

Begin the procedure with the preparation of the

medullary canal (Figures 18 and 19).

Enter the medullary canal with a 9 mm drill to a depth

of 3-5 cm (Figure 20). Take care that the drill avoids the

cortices. It is helpful to palpate the distal femoral shaft

as the drill is advanced.

Where impedance of the intramedullary canal is

anticipated, adjust the entry point accordingly.

Figure 20

Figure 19

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 19

REAMING THE MEDULLARY CANAL

Figure 21

Connect the Reamer Handle to a small diameter MBT

Revision Reamer. If power reaming, it will be necessary

to attach the modified Hudson Adapter to the Straight

Reamer.

Note: The reamer shaft contains markings in

25.4 mm increments to accommodate the various

Universal Stem/Sleeve length combinations (Figure 21).

Use the Reamer Depth Chart to determine reamer depth

for each combination of components (Figure 22).

Another option to determine reamer depth is to

measure the trial assembly against the reamer and note

the corresponding depth mark for reaming.

You may also determine the length and diameter of the

prosthetic stem extension with templates (Cat. No.

2294-99-035: SIGMA Femoral Adapter Sleeve and Stem

Template) applied to pre-operative X-ray. The S-ROM

femoral components can be found on the S-ROM

Templates (XRT-115).

The S-ROM Femoral Component accepts the

following stems, only with the use of a femoral

sleeve:

· Universal Fluted Stems of 75, 115 and 150 mm in

diameters of 10-24 mm in 2 mm increments

· Cemented Stems available in lengths of 30 and

60 mm lengths and a diameter 13 mm or 15 mm

· Cemented Tapered Stems available in lengths of

90 mm (13 mm and 15 mm diameter) and 120 mm

and 150 mm (13 mm diameter only)

Note: The Stem is the same as is currently used

with the MBT Revision Trays.

Example: Ream to the tick mark

#4 when using S-ROM femur with

31 mm Sleeve and 75 mm Press-

Fit Stem

20 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

S-ROM Femur 20 mm

31 mm

34 mm

40 mm

46 mm

Cemented

Stems

30 mm 2 2

60 mm 3 3

90 mm 4 4

120 mm 5 6

150 mm 6 7

Press-Fit

Stems

75 mm 4 4

115 mm 5 5

150 mm 6 7

REAMING THE MEDULLARY CANAL

Figure 22

In 1 mm diameter increments, sequentially open the

medullary canal with MBT Revision Reamers of

progressively greater size until firm endosteal

engagement is established.

Take care to ream the canal in line with the femoral axis

to avoid putting the implant in flexion.

Note: Do not reverse ream.

It is important that simple cortical contact of the tip not

be construed as engagement.

Cemented Stem Use

Where a cemented stem extension is indicated, perform

final reaming with a 15 mm diameter reamer for the 13

mm diameter stem extension; similarly a 17 mm

diameter reamer is used to accommodate the 15 mm

diameter stem extension.

This allows for creation of a cement mantle.

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 21

Figure 23 Figure 24

Broach

Reamer

After reaming the intramedullary canal, attach the

Threaded Shaft to the Broach Reamer and then to the

appropriate Stem Trial as determined by straight reaming

(Figure 23).

Ream to the 20 mm, 31 mm, 34 mm etch mark on the

Threaded Shaft (Figure 24).

PREPARATION OF THE METAPHYSIS – SLEEVE USE

22 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Medial SideLateral Side

Figure 26

Figure 25

PREPARATION OF THE METAPHYSIS – SLEEVE USE

When using the Broach Reamer, the next smaller

diameter Stem Trial may be used to allow for easier

reaming. The Broach Reamer will be necessary when

utilizing a 20 mm sleeve and for the beginning of larger

sequential broaching when using a 31 mm

or larger sleeve. After broach reaming has been

completed, attach the 31 mm broach to the Broach

Handle (Figure 25). Attach the appropriate Stem Trial to

the broach as determined by straight reaming. Give

close attention to the medial orientation of

the broach.

Note: The broach is asymmetrical; and the narrow

side of the broach must point medially (Figure 26).

Note: When prepping for a 20 mm sleeve, leave the

Broach Reamer and threaded shaft in the canal and

perform the subsequent femoral cuts off the reamer.

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 23

PREPARATION OF THE METAPHYSIS – SLEEVE USE

Sequentially broach to the desired dimension of 31, 34,

40 or 46 mm (Figure 27). When the LCS®/SROM etch

mark on the Broach Handle is at the planned distal

resection level, check the broach’s rotational stability. If

the broach (not the handle) moves in the canal, it is not

rotationally stable.

If the stability of the broach is unsatisfactory, move up to

the next broach size. The last broach used will be the

femoral sleeve size. The broach depth sets the extension

gap/joint line.

In patients with a large degree of distal femoral bow,

closely monitor the anterior progression of the broach

during impaction. Excessive anterior placement of the

broach may result in a loose flexion gap.

Figure 27

Planned Level of Distal Resection

24 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Figure 28

PREPARATION OF THE METAPHYSIS – SLEEVE USE

After broaching is complete, remove the Broach Handle

from the broach. With the broach seated in the femur,

attach the Threaded Shaft to the broach (Figure 28).

Distal, anterior, chamfer, and notch cuts will reference

off the Threaded Shaft/Broach assembly.

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 25

FEMORAL PREPARATION – DISTAL RESECTION

Distal Femoral Resection Guide

Distal Femoral Connector

Revision Distal Cutting Block

Figure 29

Figure 31

Figure 30

Figure 32

Distal Resection

Set the valgus angle to 7 degrees and Left/Right on the

Distal Femoral Alignment Guide by compressing the two

triggers and lock in place by rotating the blue locking

lever clockwise. Place the Femoral Alignment Guide on

the Threaded Shaft and seat against the distal femur

(Figure 29).

Rotate the knob on the Femoral Resection Guide

counterclockwise until the arrow is pointing to the

padlock symbol. Slide the Distal Femoral Connector into

the Femoral Resection Guide. Rotate the knob on the

Femoral Resection Guide clockwise. Every click moves

the Revision Distal Cutting Block 1 mm proximal or

distal. Turn the knob clockwise from 15 all the way

down to 0 (which is the padlock symbol). This will set

the block up for a 0 mm resection (Figure 30).

Slide the revision Distal Cutting Block onto the Distal

Femoral Block attachment. The tang on the block

connector will slide into the 0 mm cutting slot on the

cutting block. The trigger should engage in the hole

behind the 0 mm slot (Figure 31).

Note: An open resection will resect 4 mm less

femur. When a 0 mm open resection is desired, the

dial should be set to 4 mm.

Position the resection guide over the two legs of the

Distal Femoral Alignment Guide until the Distal Cutting

Block touches the anterior femur (Figure 32).

Note: The Revision Distal Block is equipped with 0,

4, and 8 mm saw slots. Please keep in mind that if

the resection level is not at 0 (the padlock symbol)

this will alter the resection. If the resection knob is

set at 2, for instance, the saw slots will perform 2, 6,

and 10 mm resections.

26 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

FEMORAL PREPARATION – DISTAL RESECTION

Rest the Femoral Alignment Guide against the most

prominent distal condyle. If no distal augments are

needed, proceed with pinning the distal resection block

and making the distal cuts through the 0 mm resection

slot (Figures 33 and 34).

If it is determined that a 5 mm or a 10 mm Distal

Augment will be needed on only one condyle, perform a

0 mm clean-up cut first on the prominent condyle. Then

turn the dial on the Femoral Resection Guide to 5 mm or

10 mm and make the cut on the other condyle through

the 0 mm resection slot.

Note: Do not use the saw slots on the Distal Block to

make augment cuts. The augment slots on this block

are set up in 4 mm increments instead of the needed

5 mm increments for S-ROM.

Alternatively, the LCS Revision Distal Femoral Resection

Guide may be used instead of the SIGMA Revision Distal

Femoral Resection Guide. The LCS Revision Block (Cat.

No. 2178-60-070) is already set up to accommodate

augments in increments of 5 mm.

Note: When adding 5 or 10 mm Distal Augments

to both sides of the femur, it may be necessary to

re-evaluate the depth the sleeve was broached

to, based upon the addition of augments. If the

augments require the broach to be distalized,

rebroaching should occur with a larger broach in

order to distalize the sleeve in the canal without

losing press-fit.

Figure 33

Figure 34

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 27

FEMORAL PREPARATION – DISTAL RESECTION

Figure 36

Figure 35

2. Remove femoral alignment

guide towards the T-Handle

1. Slide femoral resection

guide upwards

Release

attachment

Once the pins are in place, unlock the Distal Cutting

Block from the Distal Femoral Connector, using your

thumb and index finger to release the attachment. Slide

the Femoral Resection Guide upwards on the Alignment

Guide legs until the block connector disengages from

the Cutting Block and in one motion remove the

Femoral Alignment Guide by pulling the instruments

distally over the Threaded Shaft (Figure 35).

In many cases, little, if any, bone is removed from the

distal femur as the joint line is effectively elevated with

the removal of the primary femoral component. As the

level of resection is based on the preservation of bone

stock, each condyle is cut only to the level required to

establish a viable surface, with augmentation employed

to correct imbalance.

The resection is then performed through the slot

appropriate for each condyle, using a standard 1.19

mm thick blade (Figure 36).

Note: If a ½in. wide Standard Saw Blade is used it

can complete both medial and lateral distal femoral

cuts with the entire jig still in place.

An example of a medial

resection at 0 mm

28 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

The Femoral Cutting Guide is size specific (two blocks –

X-Small/Small and Medium). Determine the femoral

component size by pre-operative templating and

comparing the Femoral Component Trial to the size of

the femur. Use the size which gives the best medial/

lateral (M/L) coverage.

Slide the appropriately sized cutting guide over the

Threaded Shaft. Use the corresponding hole for a left or

a right knee (Figure 37).

Place the guide into neutral rotation by aligning the

anterior cortex parallel with the anterior portion of the

guide. The SIGMA Angel Wing (part number: 96-6530)

may be helpful in this step. Also use the femoral

epicondylar axis as the rotational reference.

Note: If distal augmentation will be used,

use 5 or 10 mm Box Cut Guide Spacers on the

appropriate condyle(s). Establish the proper

rotation of the A/P block first, then pin through one

each of the medial and lateral pin holes. Remove

the block from the pins, then put the appropriate

spacer(s) over the pins before replacing the A/P

block. These spacers should rest between the

cutting guide and the distal condyle(s) to fill these

gaps appropriately (part numbers: 5 mm - 63-3305A

and 10 mm - 63-3306A).

Achieve fixation of the cutting guide with 1/8 in. drill

pins, introduced through the convergent holes on the

side of the block. These Pins will need to be temporarily

removed later to move to the notch guide (Figure 38).

Attach the Removable Handles to the cutting guide

(optional).

FEMORAL A/P AND CHAMFER CUTS

Figure 37

Figure 38

PinPin

Box Cut Guide Spacer

(5 mm)

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 29

FEMORAL A/P AND CHAMFER CUTS

Anterior

Chamfer Cut

Remove Pins

Figure 39

Figure 40

Figure 41

Make the anterior cut (Figure 39) first. Proceed to make

the anterior chamfer cut through the captured slot. If

the block was previously pinned, temporarily remove one

pin at a time while making the resection.

Make the posterior chamfer cut (Figure 40) by

holding the saw blade flush with the cutting guide. If

anterior pins are being used for fixation, remove the pin

while resecting, then replace. Care should be taken to

avoid damaging posterior soft tissue.

If not previously pinned, place at least one 1/8 in

drill pin on each side of the guide. These will be

used to position the Box Cut Guide. Next, remove the

convergent pins.

Finally, remove the femoral cutting guide, leaving the 1/8

in. drill pins in place (Figure 41).

Note: It may be easier to remove the threaded shaft

first, before trying to slide the blocks off the pins.

30 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

FEMORAL BOX CUTS

Use 5 or 10 mm Box Cut Guide Spacers if distal

Augmentation Blocks will be used (Figure 42).

Slide the Hinge Femoral Box Cut Guide over the 1⁄8 in.

drill pins placed in the previous step or align with the

lines marked off the Femoral Cutting Guide. If Distal

Augmentation Blocks will be used, slide 5 or 10 mm Box

Cut Guide Spacers over the drill pins before positioning

the Box Cut Guide.

Four additional 1⁄8 in. drill holes are provided on the

anterior surface of the Box Cut Guide; 1⁄8 in. drill pins

are recommended for additional stability.

Holding the saw blade flat against the inner surface of

the Box Cut Guide, make the side cuts for the center

box (Figure 43).

Use a narrow saw blade (12.7 mm or 0.5 in), placed on

the sloped guide surface, to remove the bone block of

the center box (Figure 44).

Figure 44

Figure 42

Box Cut Guide

Hinge Box Cut Guide

Narrow Saw Blade (1⁄2 in. wide)

Saw Blade

Box Cut

Guide Spacer

1/8 in. Drill Pin

Figure 43

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 31

FINAL PREPARATION OF THE TIBIA

Figure 45

Assess proximal tibial coverage and rotation of tibial

component. Impact the appropriate Keel Punch (utilize

the cemented Keel Punch if a cement mantle is desired

or the Press-Fit Keel Punch if line-to-line contact is

desired) (Figure 45). The base plate should be positioned

to provide the best coverage of the tibial condylar

surface.

32 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

FEMORAL TRIAL INSERTION

Two femoral Augmentation Blocks are available for the

S-ROM Noiles Rotating Hinge Total Knee System. They

are 5 and 10 mm Distal Blocks. One size fits all, i.e.

X-Small, Small and Medium hinge femoral components.

If distal augmentation is required, attach the

Augmentation Block Trial(s) with bone wax to the

Femoral Component Trial (Figure 46).

Figure 46

Implant

Cat. No.

Femoral

Location

Use with S-ROM Noiles

Rotating Hinge Femoral Size

Augment

Thickness

Trial Cat. No.

623805 Distal All Sizes 5 mm 633785

623810 Distal All Sizes 10 mm 633790

Femoral Augment Block

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 33

Stem Trial

Trial Assembly inserted into

Femoral Cavity

Femoral

Component

Trial

Femoral

Sleeve Trial

Figure 47

Figure 48

Connect the Stem Trial into the appropriate Femoral

Sleeve Trial. The diameter of the Stem Trial will be the

same as the final Straight Reamer used; the size of the

Femoral Sleeve Trial will be the same as the final Femoral

Broach used (Figure 47).

Slide the Sleeve/Stem Trial assembly into the prepared

cavity in the femoral canal to allow the assembly to self

align with the broached surfaces (Figure 48).

Note: The narrow side of the Sleeve Trial

points medially.

FEMORAL TRIAL INSERTION

34 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Universal Handle Femoral Driver

Femoral Component Trial

FEMORAL TRIAL INSERTION

Slide the Femoral Component Trial onto the resected

femur, aligning the anterior cut with the posterior aspect of

the patellar flange. After the Femoral Component Trial

engages the Femoral Sleeve Trial, impact using the Femoral

Driver on the Universal Handle. Check accuracy of the

bone cuts. Revise or rebroach if necessary (Figure 49).

Note: If Distal Augmentation Blocks will be used,

fix Distal Augment Block Trials to the Femoral Trial

with bone wax before impacting the Trial onto the

femur.

Figure 49

Push down on the button on the quick release

handle and connect the femoral driver

Two ends engage

Femoral Sleeve Trial

Femoral

Component

Trial

Femoral

Sleeve Trial

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 35

TRIAL REDUCTION

Without hinge pin,“lift off”

during flexion indicates

posterior impingement

Figure 50

Figure 52

Figure 51

Slide the condyles of the Femoral Trial into the Plateau

Trial. If the insert trial lifts off the tibial baseplate during

flexion, check the posterior area for soft tissue,

osteophyte or bone impingement (Figure 50).

It is easier to insert the Hinge Pin Trial prior to placing the

insert trial into the tibial baseplate. The Hinge Pin Trial can

be inserted either medially or laterally (Figure 50).

With the leg in full extension, evaluate the mechanical

axis. The center of the femoral head, knee and talus

should all be in line (Figure 51).

The knee should be stable throughout the full range of

motion (Figure 52).

Check ligament tension and leg length.

Revision of the tibial or femoral resection may be

required if satisfactory stability cannot be achieved.

Accommodate additional bone resection with

rebroaching.

Remove the femoral trials and ensure that the rotational

alignment of the assembly is preserved.This is used as a

reference when assembling the modular implant.

Note: In patients with severe soft tissue loss,

flexion of the knee beyond 90 degrees may cause

distraction and subluxation of the tibial plateau out

of the modular tibial base. In this instance, fit the

patient with a post-operative brace, limiting flexion

to 90 degrees and no more for at least three months.

This helps soft tissue establishment of flexion

tension. Consult package insert.

Hinge Pin Trial

36 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Figure 55

IMPLANT ASSEMBLY – TIBIA

Figure 53 Figure 54

Tibial Sleeve Assembly

Note: It is imperative to assemble the Sleeve prior

to stem attachment.

Note: Sleeves and Step Wedges can only be used

together if using a 29 mm Sleeve.

Remove trial component in one piece (use as guide for

assembly of implants).

Place the MBT Revision Tray on a firm, stable, padded

surface. Set the Tibial Sleeve in an orientation that

matches the prepared canal. Matching the orientation of

the Tray/Sleeve Trial is helpful in determining appropriate

rotation of the final tibial tray/sleeve implant (Figure 53).

The sleeve can rotate 20 degrees internally or externally.

Using the Sleeve Impactor and a Mallet, impact the

sleeve onto the MBT Revision Tray. Deliver several strikes

to engage the two components (Figure 54).

Stem Component Assembly

Attach the Stem Extension to the prosthetic tray using

the two appropriate Wrenches to ensure full

engagement (Figure 55).

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 37

Implanting the Tibial Component

Thoroughly cleanse the site with pulsatile lavage.

Perforate with small drill holes on the prepared tibial

surface to facilitate penetration of methyl methacrylate

(Figure 56). Pack residual small cavitory bone defects

with cancellous autograft, if available, or allograft.

Apply methyl methacrylate cement to the proximal tibial

surface (Figure 57) or directly to the underside of the

tibial tray component.

When a Fluted Stem or a Fluted Stem with a

Metaphyseal Sleeve is used, ensure the medullary canal

remains free of cement. Clear all extruded cement with

a Curette.

Seat the Tibial Implant construct into the prepared tibia

by impacting the RP Tray Impactor and Universal Handle

assembly (Figure 58).

Figure 58

Figure 56 Figure 57

TIBIAL IMPLANTATION

38 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Figure 59

Apply cement to this side of

the distal augmentation block

Implant Assembly - Sleeve and Stem Use

Implant assembly order (with Sleeve and Stem use):

· Add distal augments if necessary

· Attach stem to sleeve

· Attach sleeve construct to femoral construct

Implantation

After assembling the femoral components, prepare one

package of bone cement according to instructions.

Apply cement to the augmentation block(s) on the side

which contacts the femoral component, and to the

corresponding surface(s) of the femoral component

(Figure 59).

Attach the augmentation block(s) to the femoral

component. Use an Augment Block Clamp to secure to

the femoral component until the cement is fully cured.

Note: When distal augmentation blocks are used

with the S-ROM Noiles Rotating Hinge femoral

component, place the Augment Block Clamp

into the distal condylar “pocket” of the femoral

component (Figure 60).

The remainder of the mixed cement may be used to

implant the patella and tibial component while the blocks

are setting.

IMPLANT ASSEMBLY – SLEEVE AND STEM USE

Figure 60

S-ROM Noiles Rotating Hinge

Femoral Component

Distal Augment

Apply cement only to this side of

the distal augmentation block

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 39

To attach the Universal Stem to the Universal Femoral

Sleeve, thread the stem onto the sleeve. Grasp the

sleeve with the Tibial Sleeve Clamp and use the Stem

Extension Wrench to grasp Universal Stem and tighten

(Figure 61).

Apply sufficient force to both Wrenches to ensure that

the Stem is secure.

Place the femoral component with the Femoral Adapter

on a firm, stable surface. Place the appropriate sleeve

and stem construct on top of the Femoral Adapter

assembly (Figure 62). Use the sleeve and femoral

construct trial to help set the final sleeve and femur

implant rotation.

Figure 61

IMPLANT ASSEMBLY – SLEEVE AND STEM USE

Figure 62

40 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

IMPLANT ASSEMBLY – SLEEVE AND STEM USE

Slide the Femoral Stem/Sleeve Impactor on top of the

stem and forcefully apply three strikes with a Mallet to

engage the two component assemblies (Figure 63).

Note: The Femoral Stem/Sleeve Impactor has

two uses, one end for use of a sleeve without a

stem extension and one end for a sleeve and stem

combination.

The definitive components are implanted in the

following order:

· Tibial tray (with stem, sleeve or wedges)

· Femoral component (with stem, sleeve and

augments)

· LPS Hinged insert

Implant the femoral component using the Femoral

Impactor (Figure 64).

Universal Handle

Figure 63

Figure 64

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 41

Figure 68

After the femoral component and tibial tray have been

cemented into place, do one final check with the trial

inserts. Once the proper thickness has been verified,

introduce the actual implant into the sterile field.

Note: Take extreme care when opening the LPS

Universal Insert to hold onto the bushings to ensure

they do not fall out.

Put the condyles of the femoral component into the

corresponding recesses in the tibial plateau.

Insert the Hinge Pin through the hole on the medial or

lateral side of the femoral component. Orient the

rectangular head of the Hinge Pin with the rectangular

recess in the femoral component (Figure 65).

Squeeze the “clothespin” of the Hinge Pin together and

insert the Hinge Pin into the femoral component. Make

sure the Hinge Pin is securely locked in place (Figure 66).

Place the LPS Universal Insert post into the cone of the

MBT Revision Implant (Figure 67).

Test the knee through full range of motion (Figure 68).

Figure 66

Hinge Pin

Needle Holder or Clamp

"Clothespin"

Figure 65

Figure 67

BEARING AND HINGE PIN INSERTION

42 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

INITIAL PATELLAR RESECTION

Measure and record the overall thickness of the patella

using a Caliper (Figure 69).

Resect approximately 7 mm of bone from the posterior

patella surface using an Oscillating Saw.

Measure and record the thickness of the resected/

removed bone in order to properly duplicate the original

thickness.

Figure 69

Caliper

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 43

INITIAL PATELLAR RESECTION

Figure 70

Figure 71

Patella Domes are available in four diameters (Figure 70).

Select a patella trial with the diameter that best matches

the patient’s patella (Figure 70).

Select the Patella Reamer Depth Adjuster that is the

same diameter as the patella trial.

Insert the Patella Reamer Depth Adjuster into the Patella

Restraining Instrument. Rotate the depth adjuster 120

degrees clockwise to lock into position (Figure 71).

38 mm

35 mm

32 mm

30 mm

Patella Reamer

Depth Adjuster

Patella Restraining

Instrument

44 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

PATELLA REAMING

Clamp the Patella Restraining Instrument assembly onto

the patella. Lock into position by turning the Thumb Nut

clockwise (Figure 72).

Insert the Patella Reamer Bushing into the appropriate set

of slots on the Patella Reamer Depth Adjuster. Slots on the

depth adjuster are marked 1, 2, 3 and 4, which indicate

the reaming depth in millimeters. To determine the correct

slot, use the formula shown in (Table 1) as a guide.

Select the Patella Reamer that matches the diameter of

the patella component to be used and insert through the

Patella Reamer Bushing into the Patella Reamer Depth

Adjuster. Ensure that the Patella Reamer is making full

contact with the bone prior to reaming. Ream until the

Patella Reamer flange makes contact with the Patella

Reamer Bushing.

Table 1

Figure 72

Turn Thumb Nut clockwise

to lock into position

Patella Reamer

Flange

Patella Reamer Bushing

Patella Reamer

Depth Adjuster

Patella Restraining

Instrument

Thickness of

selected patella

component

Measured

thickness of

bone resected

and removed

Select Slot

number

9 mm -=

7 mm 2

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 45

PATELLA DRILLING

Figure 73

Figure 74

Remove the Patella Reamer and insert the Patella Drill

Guide into the Patella Reamer Bushing. The Locating

“Pin” on the Drill Guide will insert into the hole in the

Patella Restraining Instrument (Figure 73).

Select the 3⁄16 in. Patella Shoulder Drill and prepare the

three patella peg holes by drilling through the three

larger holes in the Patella Drill Guide.

The depth of the holes drilled is correct for the length of

the pegs on the selected Patella Button (Figure 74).

Optional: Select the 1⁄8 in. Patella Shoulder Drill and drill

through the four smaller holes to enhance the cement

fixation to the patellar bone. Loosen the Thumb Nut on

the Patella Restraining Instrument and remove the entire

assembly from the patella bone.

Patella Shoulder Drill

Patella Drill Guide

Thumb Nut

Patella Reamer Bushing

Locating Pin

Patella Restraining

Instrument

Patella Reamer

Depth Adjuster

3⁄16 in. Drill Hole

Locating Pin

1⁄8 in. Drill Hole

Patella Drill Guide

46 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

TRIAL REDUCTION AND IMPLANTATION

Place the appropriate diameter Patella Trial into the

prepared patella bone. Measure the overall thickness of

the patella construct to ensure that it is the desired

thickness, i.e. equal to or 1-2 mm less than the original

patella thickness. A “no-thumbs” trial reduction and

patella tracking evaluation can now be performed.

Note: If the reconstructed patella is too thick, repeat

the reaming and drilling steps using the number 2,

3 or 4 slot on the Patella Reamer Depth Adjuster.

If a greater thickness must be removed, take

additional resection from the patella. The reaming

and drilling steps must be repeated. (Take care

to make sure the patella bone is not cut too thin.

Maintain at least 10 mm of patella bone to prevent

drill or peg penetration of the anterior cortex).

The appropriately sized Patella Dome may now be

cemented into place. A Patella Cement Clamp is

provided for this purpose (Figure 75).

Figure 75

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 47

APPENDIX 1: THE CEMENTED TIBIAL STEM EXTENSIONS

Figure 2 Figure 3

Cemented

Drill Bushing

MBT Revision

Drill Bushing

Figure 1

Cemented Stem Reamer

Align the Tibial Tray and secure with two Fixation Pins

inserted through the holes designated (Figure 1). Seat

the MBT Revision Drill bushing onto the tibia trial. Place

in the posterior holes.

Place the Cemented Drill Bushing into the MBT Revision

Drill Bushing (Figure 2).

Use the “cemented” reamer to ream to the

predetermined selected depths for tray only or the Tray

with a 30 or 60 mm cemented stem.

Remove the reamer and “cemented” bushing, leaving

the tray trial and MBT Revision Drill Bushing in place

(Figure 3).

Note: Only a 13 mm diameter cemented stem should

be used in conjunction with the MBT Revision Tray

to avoid a step off at the stem/tray junction.

48 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

APPENDIX 1: THE CEMENTED TIBIAL STEM EXTENSIONS

Tapered Reamer

Assemble the Revision Reamer Adapter onto the

Cemented Tapered Reamer.

Next, attach the modified Hudson Adapter to the

Tapered Reamer, if power reaming.

Attach the appropriately sized Cemented Stem Trial

(13 x 30 mm or 13 x 60 mm) to the Tapered Reamer, if

utilizing a cemented stem extension (Figure 4). Ream

until the Revision Reamer Adapter is flush with the MBT

Revision Drill Bushing (Figure 5).

Note: To avoid Stem Trial disengagement, do not

reverse ream.

Figure 4

Figure 5

Modified Hudson Adapter

Revision Reamer Adapter

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 49

APPENDIX 1: THE CEMENTED TIBIAL STEM EXTENSIONS

Tapered Cemented Stems

Note: Tapered Cemented Stem sizes 13 x 90/120/150

mm are compatible with MBT Revision Trays.

Ream the canal with a reamer two sizes larger than the

stem. Ream the medullary canal with a 15 mm reamer

to implant a 13 mm Tapered Cemented Stem, which

allows for a 1 mm circumferential cement mantle at the

proximal end of the stem. The cement mantle will be

greater around the distal end of the Cemented Tapered

Stem (3 mm per side).

This provides the following benefits:

· Thicker cement mantle distally helps assure that a

circumferential mantle is present and reduces the

possibility of thin or non-existent cement coverage of

the stem distally

· Stresses are greatest at the tip of the stem. A larger

cement mantle is advantageous in dissipating these

stresses. Thinner cement mantles are more prone to

breakdown when exposed to higher stresses

Tibial Keel Preparation

Place the knee in full extension and determine appropriate

rotation of the Tibial Tray. Mark the appropriate rotation

with electrocautery on the anterior tibial cortex at the

center and sides of the Alignment Handle.

Assemble the appropriate Stem Trial to the MBT Revision

Tray Trial and seat in the prepared bone bed. Impact the

Cemented Keel Punch (Figure 6).

Disconnect the Universal Handle leaving the Keel Punch in

place for trial reduction (if appropriate).

It is recommended that a Cement Restrictor be placed

at the appropriate level prior to cementing the

component. Use a Cement Gun to fill the canal with

methyl methacrylate.

Figure 6

50 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Figure 1

Figure 2

APPENDIX 2: STEP WEDGE PREPARATION

Step Wedge Augmentation

Resection for supplementary tibial augmentation may be

based on the established position of the Trial Tray. Remove

the Femoral Trial to provide greater access. Confirm

rotational alignment of the Tibial Tray Trial. Secure the Tray

with two Fixation Pins.

Attach the Tray Trial Wedge cutting attachment with the

Step Wedge Cutting Guide to the Trial Tray. The Step

Wedge Cutting Block allows for a 5, 10 or 15 mm Step

Wedge preparation as necessary. Slide the block forward

to the anterior proximal tibia and secure in place with two

Steinmann Pins through the holes marked with

(Figure 1).

Unlock the block and slide the assembly out of the block.

Disconnect the handle from the Trial Tray (Figure 2).

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 51

APPENDIX 2: STEP WEDGE PREPARATION

Trim the tibia accordingly with an Oscillating Saw so the

cut does not extend beyond the central riser (Figure 3).

Remove the Block and Pins.

Assemble the Trial Wedge to the appropriate Tibial Tray

Trial (Figure 4) and introduce into the prepared site.

Perform minimal correction with a Bone File where

indicated to ensure maximal contact.

Figure 4

Step Wedge

Cutting Block

Figure 3

52 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Confirm positioning, alignment and security of the tray

assembly. If there is old cement or sclerotic bone,

remove this first with a saw blade or burr prior to

punching. Position the MBT Revision Tibial Keel Punch at

the tray and cancellous bone interface and impact into

the keel configuration. Leave the punch in place and

perform a final trial reduction if necessary (Figure 5).

Note: Utilize the “cemented” Keel Punch when a

cement mantle is desired.

Alternative Step Wedge Preparation

This is a “free-hand” resection. Assemble the Wedge

Trial and Stem Trial to the Tibial Tray Trial. Position the

device slightly proximal to the planned resection level.

Make a conservative “free-hand” wedge resection and

then check cuts with the Trials (Figure 6).

Wedge Implant Assembly

Note: To aid wedge implant assembly, attach wedge

prior to attaching the stem attachment.

Assemble the designated wedge to the tray and secure

using the appropriate screw. Carefully tighten with the

large T-Handle Torque Driver until an audible "click" is

discerned, ensuring a full and permanent interlock

(Figure 7).

Figure 7

APPENDIX 2: STEP WEDGE PREPARATION

Figure 5 Figure 6

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 53

APPENDIX 3: THICK TRAY PREPARATION

After impacting the cement or Press-Fit Keel Punch,

remove the Keel Punch. Insert the MBT Thick Tray Trial

Adapter (15 or 25 mm) onto the Tibial Tray Trial (Figures

1 and 2).

Note: The Tibial Tray Trial must be used with the

Thick Tray Adapters as the two pieces equal the

appropriate sizing – 15 or 25 mm.

Perform the final trial reductions utilizing the same

technique as the standard MBT Revision Tray. Implant

assembly and implantation is also the same as with the

standard MBT Revision Tray. If utilizing a Wedge, refer to

the Step Wedge Preparation in Appendix 2.

Note: A Tibial Wedge can be used with all Thick

Tray sizes, except for size 2. Due to the taper, use

size 2 Tibial Wedges with size 4 MBT Revision

Thick Trays, and use size 1 Tibial Wedges with size

3 MBT Revision Thick Trays. Sleeves may be used

with all Thick Trays.

Note: Due to the taper, trial with appropriate tray

trial size. For example, a size 4 Thick Tray tapers

down to a size 2. Use the size 2 Tray Trial with the

size 4 Thick Tray Adapter. The size 3 Thick Tray

tapers down to a size 1. And the size 2 Thick Tray

tapers down to a size 0. The size 0 Tray Trial can be

found in the MBT Thick Tray Instrument Set.

Figure 1

Figure 2

54 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

IMPLANT LISTING

S-ROM Femoral Components

(hinge pin is packaged with the femur)

Universal Femoral Sleeves

Universal Press-Fit Stems

S-ROM Femoral Augments

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 55

62-3401L Medium Left S-ROM Femur

62-3401R Medium Right S-ROM Femur

62-3411L Small Left S-ROM Femur

62-3411R Small Right S-ROM Femur

62-3421L X-Small Left S-ROM Femur

62-3421R X-Small Right S-ROM Femur

1294-53-205 20 mm Cemented Femoral Sleeve

1294-53-215 31 mm Distally Porous Femoral Sleeve

1294-53-216 31 mm Fully Porous Femoral Sleeve

1294-53-225 34 mm Distally Porous Femoral Sleeve

1294-53-226 34 mm Fully Porous Femoral Sleeve

1294-53-235 40 mm Distally Porous Femoral Sleeve

1294-53-236 40 mm Fully Porous Femoral Sleeve

1294-53-245 46 mm Distally Porous Femoral Sleeve

1294-53-246 46 mm Fully Porous Femoral Sleeve

62-3805 Distal Augment, 5 mm (used on all femur sizes)

62-3810 Distal Augment, 10 mm (used on all femur sizes)

86-7410 75 mm x 10 mm Universal Fluted Stem

86-7412 75 mm x 12 mm Universal Fluted Stem

86-7414 75 mm x 14 mm Universal Fluted Stem

86-7416 75 mm x 16 mm Universal Fluted Stem

86-7418 75 mm x 18 mm Universal Fluted Stem

86-7419 75 mm x 20 mm Universal Fluted Stem

86-7420 75 mm x 22 mm Universal Fluted Stem

86-7421 75 mm x 24 mm Universal Fluted Stem

86-7424 115 mm x 10 mm Universal Fluted Stem

86-7426 115 mm x 12 mm Universal Fluted Stem

86-7428 115 mm x 14 mm Universal Fluted Stem

86-7430 115 mm x 16 mm Universal Fluted Stem

86-7432 115 mm x 18 mm Universal Fluted Stem

86-7433 115 mm x 20 mm Universal Fluted Stem

86-7434 115 mm x 22 mm Universal Fluted Stem

86-7435 115 mm x 24 mm Universal Fluted Stem

86-7438 150 mm x 10 mm Universal Fluted Stem

86-7440 150 mm x 12 mm Universal Fluted Stem

86-7442 150 mm x 14 mm Universal Fluted Stem

86-7444 150 mm x 16 mm Universal Fluted Stem

86-7446 150 mm x 18 mm Universal Fluted Stem

86-7447 150 mm x 20 mm Universal Fluted Stem

86-7448 150 mm x 22 mm Universal Fluted Stem

86-7449 150 mm x 24 mm Universal Fluted Stem

IMPLANT LISTING

56 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Universal Femoral Sleeves

S-ROM Patella

LPS Universal Inserts (compatible with S-ROM

and LPS femurs, must match femur size-to-size)

86-6401 30 mm x 13 mm Cemented Stem

(used on MBT Revision Trays size 3 and smaller)

86-6402 60 mm x 13 mm Cemented Stem

(used on MBT Revision Trays size 3 and smaller)

86-6403 30 mm x 15 mm Cemented Stem

(used on MBT Revision Trays size 4 and larger)

86-6404 60 mm x 15 mm Cemented Stem

(used on MBT Revision Trays size 4 and larger)

86-6468 90 mm x 13 mm Cemented Tapered Stem

86-6469 90 mm x 15 mm Cemented Tapered Stem

86-6498 120 mm x 13 mm Cemented Tapered Stem

86-6499 150 mm x 13 mm Cemented Tapered Stem

62-1630 30 mm S-ROM Dome Patella

62-1632 32 mm S-ROM Dome Patella

62-1635 35 mm S-ROM Dome Patella

62-1638 38 mm S-ROM Dome Patella

1987-27-112 X-Small 12 mm LPS Universal Insert

1987-27-114 X-Small 14 mm LPS Universal Insert

1987-27-116 X-Small 16 mm LPS Universal Insert

1987-27-118 X-Small 18 mm LPS Universal Insert

1987-27-121 X-Small 21 mm LPS Universal Insert

1987-27-123 X-Small 23 mm LPS Universal Insert

1987-27-126 X-Small 26 mm LPS Universal Insert

1987-27-128 X-Small 28 mm LPS Universal Insert

1987-27-131 X-Small 31 mm LPS Universal Insert

1987-27-212 Small 12 mm LPS Universal Insert

1987-27-214 Small 14 mm LPS Universal Insert

1987-27-216 Small 16 mm LPS Universal Insert

1987-27-218 Small 18 mm LPS Universal Insert

1987-27-221 Small 21 mm LPS Universal Insert

1987-27-223 Small 23 mm LPS Universal Insert

1987-27-226 Small 26 mm LPS Universal Insert

1987-27-228 Small 28 mm LPS Universal Insert

1987-27-231 Small 31 mm LPS Universal Insert

1987-27-312 Medium 12 mm LPS Universal Insert

1987-27-314 Medium 14 mm LPS Universal Insert

1987-27-316 Medium 16 mm LPS Universal Insert

1987-27-318 Medium 18 mm LPS Universal Insert

1987-27-321 Medium 21 mm LPS Universal Insert

1987-27-323 Medium 23 mm LPS Universal Insert

1987-27-326 Medium 26 mm LPS Universal Insert

1987-27-328 Medium 28 mm LPS Universal Insert

1987-27-331 Medium 31 mm LPS Universal Insert

IMPLANT LISTING

Cat. No. Size (mm) A/P M/L Stem Length Tray Thickness

1294-35-110 1 39.0 59.2 61.8 4.8

1294-35-115 1.5 40.7 61.8 61.8 4.8

1294-35-120 2 42.6 64.6 61.8 4.8

1294-35-125 2.5 44.2 67.1 61.8 4.8

1294-35-130 3 45.8 69.6 61.8 4.8

1294-35-140 4 49.3 74.9 61.8 4.8

1294-35-150 5 53.1 80.6 61.8 4.8

1294-35-160 6 57.2 86.8 61.8 4.8

1294-35-215 2+15 42.6 64.6 61.8 15

1294-35-225 2+25 42.6 64.6 61.8 25

1294-35-315 3+15 45.8 69.6 61.8 15

1294-35-325 3+25 45.8 69.6 61.8 25

1294-35-415 4+15 49.3 74.9 61.8 15

1294-35-425 4+25 49.3 74.9 61.8 25

Cat. No. Size (mm) A/P M/L Height

1294-54-000 29 26 29 40

1294-54-140 (Cemented) 29 26 29 40

1294-54-100 37 27 37 40

1294-54-110 45 27 45 40

1294-35-120 53 31 53 40

1294-35-130 61 34 61 40

MBT Revision Tray

MBT Revision Sleeve

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 57

IMPLANT LISTING

Cat. No. Size (mm)

1294-56-110 1-5

1294-56-111 1-10

1294-56-112 1-15

1294-56-115 1.5-5

1294-56-116 1.5-10

1294-56-117 1.5-15

1294-56-120 2-5

1294-56-121 2-10

1294-56-122 2-15

1294-56-125 2.5-5

1294-56-126 2.5-10

1294-56-127 2.5-15

Cat. No. Size (mm)

1294-56-130 3-5

1294-56-131 3-10

1294-56-132 3-15

1294-56-135 4-5

1294-56-136 4-10

1294-56-137 4-15

1294-56-140 5-5

1294-56-141 5-10

1294-56-142 5-15

1294-56-145 6-5

1294-56-146 6-10

1294-56-147 6-15

MBT Revision Augments

Note: If a tibial sleeve is used, MBT Revision Augments are only

compatible with the 29 mm sleeve.

58 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

COMPATIBILITY CHART

LPS

XX-Small

Femoral

Component

LPS X-Small

Femoral

Component

and

S-ROM

X-Small

Femoral

Component

S-ROM

Small

Femoral

Component

S-ROM

Medium

Femoral

Component

Tray No. M/L 56.6 66.7 66.7 71.2

MBT Revision Tray

Size 1 1294-35-110 59.2

MBT Revision Tray

Size 1.5 1294-35-115 61.8

MBT Revision Tray

Size 2 1294-35-120 64.6

MBT Revision Tray

Size 2.5 1294-35-125 67.1

MBT Revision Tray

Size 3 1294-35-130 69.6

MBT Revision Tray

Size 4 1294-35-140 74.9

MBT Revision Tray

Size 5 1294-35-150 80.6

MBT Revision Tray

Size 6 1294-35-160 86.8

LPS Universal inserts must match S-ROM or LPS femoral component size-to-size.

For example, XX-Small femoral component = XX-Small polyethylene; Small femoral component = Small polyethylene, etc.

3

3

3 3 3

3 3 3

3 3 3 3

3 3 3 3

3 3 3 3

3 3 3 3

signifies preferred match

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 59

MBT REVISION PREPARATION CASE

CAT. NO. 2178-64-100

Description Cat. No.

A MBT Revision Cemented Stem Reamer, 13 mm 2178-63-185

B Tibial Cutting Block, 2 Degree 2178-40-086

C MBT Revision Reamer Adapter 2178-63-128

D MBT Revision Press-Fit Tibial Punch 2178-63-118

E MBT Revision Cemented Tibial Punch 2178-63-120

F Pin Driver 2490-94-000

G MBT Revision Drill Bushing 2178-63-100

H Pin Puller 96-6515

I SP2 IM Rod, 400 mm 96-6120

J SP2 IM Rod Handle 99-2011

K MBT Revision Cemented Bushing, 13 mm 2178-63-196

L MBT Revision Tapered Press-Fit Reamer 2178-63-104

M MBT Revision Tapered Cemented Reamer 2178-63-106

N Steinman Pins (Package of 10) 86-9117

Top Tray

A

C

D F

G

B

H

NM

L

I

E

J

K

60 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Description Cat. No.

A MBT Revision 2-Degree Tibial Broaches 29 mm 2178-63-109

MBT Revision 2-Degree Tibial Broaches 37 mm 2178-63-111

MBT Revision 2-Degree Tibial Broaches 45 mm 2178-63-113

MBT Revision 2-Degree Tibial Broaches 53 mm 2178-63-115

MBT Revision 2-Degree Tibial Broaches 61 mm 2178-63-117

B MBT Tray Sleeve Trials 29 mm 2294-54-000

MBT Tray Sleeve Trials 37 mm 2294-54-100

MBT Tray Sleeve Trials 45 mm 2294-54-110

MBT Tray Sleeve Trials 53 mm 2294-54-120

MBT Tray Sleeve Trials 61 mm 2294-54-130

C LCS Completion Tibial Stylus 2178-40-045

D MBT Revision Tibial Broach Handle 96-6521

E Revision Sleeve Impactor 2178-63-124

F Revision Femoral Sleeve/Stem Impactor 2178-63-126

G SP2 Universal Handle 96-6520

H SP2 IM Tibial Alignment Device 96-6315

I MBT Tibial Impactor 9505-01-558

J MBT Revision Tibial View Plate, Size 1 2178-65-110

MBT Revision Tibial View Plate, Size 1.5 2178-65-115

MBT Revision Tibial View Plate, Size 2 2178-65-120

MBT Revision Tibial View Plate, Size 2.5 2178-65-125

MBT Revision Tibial View Plate, Size 3 2178-65-130

MBT Revision Tibial View Plate, Size 4 2178-65-140

MBT Revision Tibial View Plate, Size 5 2178-65-150

MBT Revision Tibial View Plate, Size 6 2178-65-160

MBT REVISION PREPARATION CASE

CAT. NO. 2178-64-100

A B C

E

DH

FI J

G

Bottom Tray

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 61

MBT REVISION STEM TRIALS AND INSTRUMENTS CASE

CAT. NO. 2178-64-110

Top Tray

Description Cat. No.

A Revision Femoral/Tibial Sleeve Clamp 2178-63-134

B SIGMA Tibial Cemented Stem Trial, Sizes 2-3, 13 x 60 mm 86-6502

C SIGMA Tibial Cemented Stem Trial, Sizes 1.5-3, 13 x 30 mm 86-6501

D Stem Trial Extractor 86-5226

E Fluted Tibial Stem Trials – 75 mm

75 x 10 mm 86-6874

75 x 12 mm 86-6875

75 x 14 mm 86-6876

75 x 16 mm 86-6877

75 x 18 mm 86-6878

75 x 20 mm 86-6879

75 x 22 mm 86-6880

75 x 24 mm 86-6881

A

B F GE

C

D

62 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

MBT REVISION STEM TRIALS AND INSTRUMENTS CASE

CAT. NO. 2178-64-110

Top Tray

Description Cat. No.

F Fluted Tibial Stem Trials – 115 mm

115 x 10 mm 86-6882

115 x 12 mm 86-6883

115 x 14 mm 86-6884

115 x 16 mm 86-6885

115 x 18 mm 86-6886

115 x 20 mm 86-6887

115 x 22 mm 86-6888

115 x 24 mm 86-6889

G Fluted Tibial Stem Trials – 150 mm

150 x 10 mm 86-6890

150 x 12 mm 86-6891

150 x 14 mm 86-6892

150 x 16 mm 86-6893

150 x 18 mm 86-6894

150 x 20 mm 86-6895

150 x 22 mm 86-6896

150 x 24 mm 86-6897

A

B F GE

C

D

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 63

MBT REVISION STEM TRIALS AND INSTRUMENTS CASE

CAT. NO. 2178-64-110

Bottom Tray

Description Cat. No.

A Press-Fit Rod Wrench 86-5189

B SIGMA Tibial Cemented Stem Trial, Sizes 2-3, 13 x 60 mm 86-6502

C SIGMA Tibial Cemented Stem Trial, Sizes 1.5-3, 13 x 30 mm 86-6501

D Fluted Tibial Stem Trials – 75 mm

75 x 10 mm 86-6874

75 x 12 mm 86-6875

75 x 14 mm 86-6876

75 x 16 mm 86-6877

75 x 18 mm 86-6878

75 x 20 mm 86-6879

75 x 22 mm 86-6880

75 x 24 mm 86-6881

A

B D E F

C

64 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

MBT REVISION STEM TRIALS AND INSTRUMENTS CASE

CAT. NO. 2178-64-110

Bottom Tray

Description Cat. No.

E Fluted Tibial Stem Trials – 115 mm

115 x 10 mm 86-6882

115 x 12 mm 86-6883

115 x 14 mm 86-6884

115 x 16 mm 86-6885

115 x 18 mm 86-6886

115 x 20 mm 86-6887

115 x 22 mm 86-6888

115 x 24 mm 86-6889

F Fluted Tibial Stem Trials – 150 mm

150 x 10 mm 86-6890

150 x 12 mm 86-6891

150 x 14 mm 86-6892

150 x 16 mm 86-6893

150 x 18 mm 86-6894

150 x 20 mm 86-6895

150 x 22 mm 86-6896

150 x 24 mm 86-6897

A

B D E F

C

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 65

MBT REVISION REAMERS CASE

CAT. NO. 2178-64-105

Description Cat. No.

A Press-Fit Rod Wrench 86-5189

B I.M. Rod Sleeve Guide, 12 mm 2178-63-187

C I.M. Rod Sleeve Guide, 14 mm 2178-63-188

D LCS Reamer Depth Scale 2178-63-102

E Revision Femoral/Tibial/Sleeve Clamp 2178-63-134

F I.M. Reamer, 9 mm 2178-56-045

G MBT Revision Reamers

MBT Revision Reamer, 10 mm 2178-63-170

MBT Revision Reamer, 11 mm 2178-63-171

MBT Revision Reamer, 12 mm 2178-63-172

MBT Revision Reamer, 13 mm 2178-63-173

MBT Revision Reamer, 14 mm 2178-63-174

MBT Revision Reamer, 15 mm 2178-63-175

Top Tray

A

D

G

F E

B C

66 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

Description Cat. No.

A MBT Revision Reamers

MBT Revision Reamer, 16 mm 2178-63-176

MBT Revision Reamer, 17 mm 2178-63-177

MBT Revision Reamer, 18 mm 2178-63-178

MBT Revision Reamer, 19 mm 2178-63-179

MBT Revision Reamer, 20 mm 2178-63-180

MBT Revision Reamer, 21 mm 2178-63-181

MBT Revision Reamer, 22 mm 2178-63-182

MBT Revision Reamer, 23 mm 2178-63-183

MBT Revision Reamer, 24 mm 2178-63-184

B I.M. Rod Sleeve Guide, 16 mm 2178-63-189

C I.M. Rod Sleeve Guide, 18 mm 2178-63-190

D I.M. Rod Sleeve Guide, 20 mm 2178-63-191

E I.M. Rod Sleeve Guide, 22 mm 2178-63-192

F I.M. Rod Sleeve Guide, 24 mm 2178-63-193

G I.M. Rod Sleeve Guide, 26 mm 2178-63-194

H MBT Revision T-Handle 2178-63-137

I Modified Hudson Adapter 2178-63-136

MBT REVISION REAMERS CASE

CAT. NO. 2178-64-105

Bottom Tray

A

H

I

B

C

DF

EG

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 67

MBT REVISION WEDGE TRIALS AND INSTRUMENTS

CAT. NO. 2178-64-115

Top Tray

Description Cat. No.

A Size 1, 5 mm 2294-56-110

Size 1, 10 mm 2294-56-111

Size 1, 15 mm 2294-56-112

B Size 1.5, 5 mm 2294-56-115

Size 1.5, 10 mm 2294-56-116

Size 1.5, 15 mm 2294-56-117

C Size 2, 5 mm 2294-56-120

Size 2, 10 mm 2294-56-121

Size 2, 15 mm 2294-56-122

D Size 2.5, 5 mm 2294-56-125

Size 2.5, 10 mm 2294-56-126

Size 2.5, 15 mm 2294-56-127

E Size 3, 5 mm 2294-56-130

Size 3, 10 mm 2294-56-131

Size 3, 15 mm 2294-56-132

F Size 4, 5 mm 2294-56-135

Size 4, 10 mm 2294-56-136

Size 4, 15 mm 2294-56-137

G Size 5, 5 mm 2294-56-140

Size 5, 10 mm 2294-56-141

Size 5, 15 mm 2294-56-142

H Size 6/7, 5 mm 2294-56-145

Size 6/7, 10 mm 2294-56-146

Size 6/7, 15 mm 2294-56-147

A B C D E F G H

Size 1

5 mm

10 mm

15 mm

5 mm

10 mm

15 mm

Size 1.5 Size 2 Size 2.5 Size 3 Size 4 Size 5 Size 6/8

68 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

MBT REVISION WEDGE TRIALS AND INSTRUMENTS

CAT. NO. 2178-64-115

Bottom Tray

Description Cat. No.

A MBT Revision Tray Trial, Size 1 2294-36-110

MBT Revision Tray Trial, Size 1.5 2294-36-115

MBT Revision Tray Trial, Size 2 2294-36-120

MBT Revision Tray Trial, Size 2.5 2294-36-125

MBT Revision Tray Trial, Size 3 2294-36-130

MBT Revision Tray Trial, Size 4 2294-36-140

MBT Revision Tray Trial, Size 5 2294-36-150

MBT Revision Tray Trial, Size 6 2294-36-160

B MBT Revision Tray Trial with Stem, Size 1 2294-35-110

C MBT Revision Tray Trial with Stem, Size 1.5 2294-35-115

D MBT Revision Tray Trial with Stem, Size 2 2294-35-120

E MBT Revision Tray Trial with Stem, Size 2.5 2294-35-125

F MBT Revision Cutting Block 2178-63-122

G Tibial Wedge Trial Screwdriver 86-0277

H MBT Wedge Cutting Attachment 2178-63-130

I SP2 Alignment Rods 99-1016

J Tibial Trial Alignment Handle 96-6330

K MBT Revision Trial Post 2178-63-132

L Modular Plus Torque Driver 86-0284

M MBT Tray Trial Fixation Pins 2178-30-123

N MBT Revision Tray Trial with Stem, Size 3 2294-35-130

O MBT Revision Tray Trial with Stem, Size 4 2294-35-140

P MBT Revision Tray Trial with Stem, Size 5 2294-35-150

Q MBT Revision Tray Trial with Stem, Size 6 2294-35-160

A

B C

F

G

HIK

J

D E

M

QPON

L

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 69

Bottom Tray

SIGMA HP REVISION FEMORAL PREP INSTRUMENT CASE

CAT. NO. 2011-03-049

Description Cat. No.

A Visualization Wing 96-6530

B Completion Revision Femoral Tapered Reamer 2178-60-030

C Universal Revision Femoral Broach Reamer 96-1671

D Universal Revision Femoral Broach 31 mm 96-1683

E Universal Revision Femoral Broach 34 mm 96-1684

F Universal Revision Femoral Broach 40 mm 96-1685

G Universal Revision Femoral Broach 46 mm 96-1686

H SIGMA HP Revision Adapter Removable Shaft 2011-03-029

I SIGMA HP Distal Femoral Resection Guide 9505-01-235

J SIGMA HP Distal Femoral Connector 9505-01-238

K SIGMA HP Revision Distal Femoral Block 9505-01-239

L SIGMA HP Distal Femoral Alignment Guide 9505-01-234

M Universal Revision Femoral Broach Handle 96-1682

A

B C D

M

E F G

I

K

J

L

H

70 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

SIGMA HP REVISION FEMORAL TRIAL INSTRUMENT CASE

CAT. NO. 2011-03-050

Top Tray

Description Cat. No.

A LCS/SIGMA Revision Femoral Sleeve Trial 20 mm 2294-53-100

B LCS/SIGMA Revision Femoral Sleeve Trial 31 mm 2294-53-110

C LCS/SIGMA Revision Femoral Sleeve Trial 34 mm 2294-53-120

D LCS/SIGMA Revision Femoral Sleeve Trial 40 mm 2294-53-130

E LCS/SIGMA Revision Femoral Sleeve Trial 46 mm 2294-53-140

F Modular Plus Torque Driver 86-0284

G SIGMA HP Revision TC3 Box Trial Size 2 2011-03-011

H SIGMA HP Revision TC3 Box Trial Size 2.5 2011-03-012

I SIGMA HP Revision TC3 Box Trial Size 3 2011-03-013

J SIGMA HP Revision TC3 Box Trial Size 4 2011-03-014

K SIGMA HP Revision TC3 Box Trial Size 5 2011-03-015

L SIGMA HP Revision Femoral Adapter Shift Tool 2011-03-057

M SIGMA Femoral Adapter Sleeve Bolt Trial Neutral 2011-03-052

N SIGMA Femoral Adapter Stem Bolt Trial Neutral 2011-03-051

O Femoral Augment Plug Puller 86-5151

P SP2 Torque Driver Handle Extension 96-6301

Q Large Fragment Screwdriver Shank 8242-19-000

R 2.0 Nm Torque-limiting Screwdriver 2141-18-001

S Femoral Adapter Torque Wrench 96-1673

T Femoral Adapter Holding Clamp 96-1674

A B C

O

Q

P

R

N

M K

L

S

T

ED

F G H I J

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 71

LPS HINGE INSERT TRIALS

Description Cat. No.

A Xsm Hinged Insert Trials

LPS Hinge Insert Trial 12 mm, Xsm 2987-22-112

LPS Hinge Insert Trial 14 mm, Xsm 2987-22-114

LPS Hinge Insert Trial 16 mm, Xsm 2987-22-116

LPS Hinge Insert Trial 18 mm, Xsm 2987-22-118

LPS Hinge Insert Trial 21 mm, Xsm 2987-22-121

LPS Hinge Insert Trial 23 mm, Xsm 2987-22-123

LPS Hinge Insert Trial 26 mm, Xsm 2987-22-126

LPS Hinge Insert Trial 28 mm, Xsm 2987-22-128

B Sm Hinged Insert Trials

LPS Hinge Insert Trial 12 mm, Sm 2987-22-212

LPS Hinge Insert Trial 14 mm, Sm 2987-22-214

LPS Hinge Insert Trial 16 mm, Sm 2987-22-216

LPS Hinge Insert Trial 18 mm, Sm 2987-22-218

LPS Hinge Insert Trial 21 mm, Sm 2987-22-221

LPS Hinge Insert Trial 23 mm, Sm 2987-22-223

LPS Hinge Insert Trial 26 mm, Sm 2987-22-226

LPS Hinge Insert Trial 28 mm, Sm 2987-22-228

C Med Hinged Insert Trials

LPS Hinge Insert Trial 12 mm, Med 2987-22-312

LPS Hinge Insert Trial 14 mm, Med 2987-22-314

LPS Hinge Insert Trial 16 mm, Med 2987-22-316

LPS Hinge Insert Trial 18 mm, Med 2987-22-318

LPS Hinge Insert Trial 21 mm, Med 2987-22-321

LPS Hinge Insert Trial 23 mm, Med 2987-22-323

LPS Hinge Insert Trial 26 mm, Med 2987-22-326

LPS Hinge Insert Trial 28 mm, Med 2987-22-328

A

B

C

72 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

LPS HINGE INSERT TRIALS

Description Cat. No.

A XXSm Hinged Insert Trials

LPS Hinge Insert Trial XX-Sm 12 mm 2987-22-012

LPS Hinge Insert Trial XX-Sm 14 mm 2987-22-014

LPS Hinge Insert Trial XX-Sm 16 mm 2987-22-016

LPS Hinge Insert Trial XX-Sm 18 mm 2987-22-018

LPS Hinge Insert Trial XX-Sm 21 mm 2987-22-021

LPS Hinge Insert Trial XX-Sm 23 mm 2987-22-023

B 31mm Hinged Insert Trials

LPS Hinge Insert Trial 31 mm, Xsm 2987-22-131

LPS Hinge Insert Trial 31 mm, Sm 2987-22-231

LPS Hinge Insert Trial 31 mm, Med 2987-22-331

C MBT Rev Trial Post 2178-63-132

D LPS Hinge Pin Trial 2987-15-000

D

A

B

C

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 73

S-ROM HINGE FEMORAL INSTRUMENTS

Description Cat. No.

A S-ROM Driver Femoral 633802

B S-ROM Knee Aug Blk Cem Clamp 633810

C S-ROM Separator,Femoral Sleeve 634182

D Sleeve/Stem Extractor 86-5226

E S-ROM NRH Dist Fem Aug Trl 5 mm 633785

F S-ROM NRH Dist Fem Aug Trl 10 mm 633790

G S-ROM NRH Hinge Pin Trial 634133

H S-ROM Universal Handle 633806a

I S-ROM NRH Fem Trial Right Med 634131r

J S-ROM NRH Fem Trial Left Med 634132l

K S-ROM NRH Fem Trial Right Small 634151l

L S-ROM NRH Fem Trial Left Small 634151r

M S-ROM NRH Fem Trial Right Xsmall 634161

N S-ROM NRH Fem Trial Left Xsmall 634161

A G

D

C

B E

F

H

I J K L

M N

74 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique

S-ROM HINGE FEMORAL INSTRUMENTS

Description Cat. No.

A S-ROM Guide Anterior Reference 633370a

B S-ROM Xsm/Sm A/P Block 2163-11-001

C S-ROM Med A/P Block 2163-11-004

D S-ROM NRH Fem Box Cut Guide 633385

E S-ROM Box Cut Guide Augment Space, 5 mm 633305a

F S-ROM Box Cut Guide Augment Space, 10 mm 633306a

G SP2 Removable Handles 96-6147

H Femoral Locating Device Outrigger 96-6112

I Femoral Locating Device 96-6110

J Distal Femoral Cutting Block 96-6115

C

B

F E

A G

H

I

D

J

Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 75

IMPORTANT:

This Essential Product Information sheet does not include all of the information

necessary for selection and use of a device. Please see full labeling for all

necessary information.

INDICATIONS AND USAGE:

The NOILES Rotating Hinge Knee is indicated for use with PMMA bone cement in

primary or revision cases in patients:

• who have reached skeletal maturity and

• for whom the surgeon has decided to resect both cruciate ligaments or whose

cruciate ligaments are absent or incompetent and

• who exhibit insufficiency of lateral/collateral ligaments and other soft

supporting tissue due to the following conditions:

• Rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis

secondary to a variety of diseases and anomalies

• Failure of a previous knee reconstruction procedure

• Trauma

CONTRAINDICATIONS:

1. Active infection or history of general infections or local infectious disease.

2. Vascular insufficiency, muscular atrophy or neuromuscular disease in the

affected limb.

3. Advanced loss of osteochondral structure that would preclude proper fixation

of the prosthesis.

4. Tumors of the supporting bone structure, systemic and metabolic disorders

leading to progressive deterioration of solid bone support.

5. Drug or alcohol addiction, or limiting neuropathic disease.

6. Skeletal immaturity.

7. Obesity or very active lifestyle that can produce loads on the prosthesis that

can lead to failure of the fixation of the device or device itself.

8. Allergic reaction to the implant materials.

9. Inadequate flexor and extensor mechanism necessary to achieve a functional

prosthetic joint.

WARNINGS:

Improper prosthesis selection or alignment, inadequate fixation, use where

contraindicated or in patients whose medical, physical, mental, or occupational

conditions will likely result in extreme stresses to the implant, may result in

premature failure due to loosening, fracture, or wear.

Post-operative care is extremely important. The patient should be instructed on

the limitations of the device and should be cautioned regarding load bearing,

ranges of motion, and activity levels permissible. Early motion and load bearing

should be carefully controlled.

The S-ROM tibial base, tibial sleeve, tibial stem extension, and tibial

augmentation blocks may not be used with the NOILES Posterior Stabilized Knee.

CAUTION: Federal (USA) law restricts this device to sale by or on the order

of a physician.

PRECAUTIONS:

The NOILES Rotating Hinge Knee is designed to articulate from 6 degrees

hyperextension to 110 degrees flexion. If, due to grossly inadequate soft tissue

integrity, flexion beyond 90 degrees causes luxation of the plateau assembly out

of the tibial base, the patient must have a knee brace posto-peratively to limit

flexion to 90 degrees. In such cases, the surgeon should consider closing the

wound with the knee in full extension.

The size of the tibial plateau assembly must correspond with the size of the

femoral component.

The size of the tibial augmentation block must correspond to the size of the

tibial base.

Femoral sleeves are required when using femoral stem extensions.

A femoral plug is required with the femoral sleeve when a femoral stem

extension is not used.

A tibial cap is required with the tibial sleeve when a tibial stem extension is

not used.

Tibial augmentation blocks cannot be used when tibial sleeves are being used.

An implant should never be reused. Any implant, once used, should be discarded.

Even though it appears undamaged, it may have small defects and/or internal

stress patterns that may lead to failure. Likewise, a new implant should be

handled carefully to avoid damage that could compromise the integrity of the

device and cause early failure or loosening.

The wear rate of prosthesis contact surfaces is greatly accelerated if loose

fragments of bone cement become detached and act as an abrasive in the

bearing surfaces. When using bone cement, care should be taken to remove all

excess cement from the periphery of the implant.

DePuy’s Single Use devices have not been designed to undergo or withstand any

form of alteration, such as disassembly, cleaning or re-sterilization, after a single

patient use. Reuse can potentially compromise device performance and patient

safety.

ADVERSE EFFECTS:

Fracture may occur due to improper preparation of the implant site or if excessive

force is used during seating of the implant. Transient peroneal palsy has been

reported following total knee arthroplasty, especially after correction of severe

flexion or valgus deformities.

Patients have complained of persistent pain and stiffness following total knee

arthroplasty. In addition, patellar tendon rupture, femoral-tibial subluxation or

dislocation, and persistent ligamentary laxity have been reported with the use of

total knee implants. Infection and loosening have been reported following total

joint arthroplasty, as have wear and failure due to fracture of knee prosthesis

components.

Histological reactions have been reported as an apparent response to exposure to

a foreign material. The actual clinical significance of these reactions is unknown.

Serious adverse side effects may necessitate surgical intervention.

The third party trademarks used herein are trademarks of their respective owners.

S-ROM® MODULAR TOTAL KNEE SYSTEM | NOILES™ ROTATING HINGE KNEE SYSTEM

DePuy Orthopaedics, Inc.

700 Orthopaedic Drive

Warsaw, IN 46582

T. +1 (800) 366-8143

www.depuysynthes.com

© DePuy Synthes Joint Reconstruction, a division of DOI 2014. All rights reserved.

0612-85-510 (Rev. 3) EO 1/14