Attune Surgical Technique Intuition Instruments

2014-02-28

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Surgical Technique

0003

Introduction

This surgical technique provides guidelines for the implantation
of the ATTUNE™ Knee System family of fixed bearing knees
with the ATTUNE™ INTUITION™ Instrumentation.
The ATTUNE INTUITION Instrumentation is intended for use
with the ATTUNE Knee System Implants only and should not
be considered interchangeable with any other instrumentation
unless specifically noted in the surgical technique.
ATTUNE Knee System Implants are available in one configuration
which allows for cruciate retaining (CR) or cruciate sacrificing (CS)
applications and another configuration which allows for posterior
stabilized (PS) applications.

Contents

Product Rationale

Key Surgical Steps Summary

Incision and Exposure

Pinning 6
Pinning Technique

Distal Femoral Resection

Distal Femoral Resection - Instrument Assembly

Distal Femoral Resection

Tibial Alignment and Resection - Instrument Assembly

Tibial Alignment and Resection

Extension Gap Assessment and Balancing

Measured Femoral Sizing and Rotation

Balanced Femoral Sizing and Rotation

Femoral Preparation

Posterior Condyle Preparation

Femoral Resection - PS Notch Cuts

Trial Reduction

Trial Components

Tibial Preparation

Patella Resection and Preparation – Instrument Assembly

Patella Resection

Patella Preparation

Tibial Base Implantation

Femoral Component Implantation

Tibial Insert Implantation

Final Patella Preparation

Patella Component Implantation

Closure 66
Flexion/Extension Gap Chart

Compatibility Data

Symbols on Surgical Instruments

Surgical Technique

The ATTUNE™ INTUITION™ Instrumentation is
unique in its ability to combine the surgical
process with the implant options to allow
the surgeon to balance the soft tissue and
precisely control the implant position and
fit for each patient. These instruments are
intuitive to use and reduce steps throughout
the surgical process, providing reduced effort
to the entire OR team.

Precise Control
Intuitive instrumentation combined with a
comprehensive range of sizes gives you precise
control over the implant fit and position.
Designed Clarity
Reduced learning curve, more certainty.
Design features like red actuators, highcontrast markings and quick set/release
functions make ATTUNE™ INTUITION™
Instruments clear and easy to use from
the moment you pick them up.
Efficient Path
Single layer trays, lightweight, and fewer
instruments are just a few efficiencies that
reduce your effort from start to finish.

Key Surgical Steps Summary

Incision and Exposure

Femoral Alignment and
Distal Resection

Tibial Alignment and
Proximal Resection

Extension Gap Assessment
and Balancing

Femoral Preparation

Trial Reduction

Tibial Preparation

Measured Femoral Sizing and Rotation

Balanced Femoral Sizing and Rotation

Note: All resections are done
using a 1.19 mm Saw Blade to
maximize accuracy through
the Slotted Cutting Guides.

Femoral Lug Hole Preparation

Patella Resection and
Final Patella Preparation

Final Component Implantation

Incision and Exposure

The ATTUNE INTUITION Instruments are
designed for both standard open and
minimally invasive approaches to the knee.
Incision and exposure should be done using
the surgeon’s preferred technique.

INFORMATION
Excise any hypertrophic synovium and a portion of

Many of the instruments on the following pages are

the infrapatellar fat pad to allow access to the medial,

made of polymer materials. As with any composite

lateral, and intercondylar spaces. Before proceeding,

or polymer-based instrument, it is important to allow

consider removing prominent osteophytes, particularly

adequate drying time after cleaning.

medial and lateral osteophytes, as they can affect soft
tissue balancing.

Pinning

The ATTUNE Knee System has specifically designed
pins to increase the stability and functionality
of the instruments. The ATTUNE INTUITION
Instruments are designed to be used with the
Single-Use Pin Pack (2544-00-111) that contains
Universal Pins and Threaded Headed Pins.

The Universal Pin* can be drilled in or hammered
in, and drilled out or pulled out using the Pin Jack.
Universal Pin
The Threaded Headed Pin* is designed to be
inserted and removed with a Power Drill. These
pins are best used to secure blocks against a flat

Threaded Headed Pin

surface such as cut bone.
*Included in the Pin Pack

The Threaded Non-Headed Pin is also available
and is designed to be inserted and removed with
a Power Drill.

Threaded Non-Headed Pin

Pin Jack

Power Driver

Pinning Technique

Correct Pinning

Incorrect Pinning

Headed pins are best used to secure blocks against a flat surface
such as cut bone, however, if used on uncut bone with a curved
surface, be careful that the Headed Pins are not overtightened
as this can lead to tilting and malalignment of the block.

Distal Femoral Resection

With the knee in flexion, remove osteophytes
from the intercondylar notch. Position the
Step Drill to enter the intramedullary canal
slightly superior and medial to the midline of
the trochlea, 7 mm to 10 mm anterior to the
origin of the PCL.
In the proper position, the Step Drill should
pass easily into the femoral canal.

Use the step feature of the Step Drill to
increase the diameter of the hole. This will
allow depressurization of the canal when
the IM Rod is inserted.

Distal Femoral Resection – Instrument Assembly

Distal Femoral Jig Assembly
Order of Assembly:
1. Rotate the Resection Knob of the Outrigger
counterclockwise until the padlock symbol

3. Rotate the Resection Knob clockwise to set
the desired resection level.

is aligned with the arrow.
4. Engage the Distal Femoral Cutting Block
2. Insert the Outrigger Slide into the
Outrigger.

with the Outrigger Slide and the Cutting
Block Clip.

Resection Knob

Outrigger

Pull Back

Outrigger Slide

Cutting Block Clip

Distal Femoral
Cutting Block

Distal Femoral Resection – Instrument Assembly

A 9 mm resection will match the thickness of the implant. The
arrow on the Outrigger, near the Resection Knob, indicates the
resection level when using the Cutting Slot. Each click moves
the Distal Femoral Cutting Block 1 mm proximal or distal.

Distal Resection Depth

4 mm difference between a
Slotted and Non-Slotted resection

Resection Knob adjusts
distal resection depth

Distal Femoral Resection

Set the desired valgus angle (left or right 0 degrees to 9 degrees) on the Distal Femoral
Jig by pulling the V/V Dial toward the
Femoral Handle, rotating it clockwise or
counterclockwise to the appropriate setting.
Distal Plate

V/V Indicator
Cap

Fixation
Pin Holes

V/V Dial

INFORMATION
Be sure that the Varus/Valgus Dial is FULLY disengaged
by sliding it back from the Distal Plate before rotating it.

Distal Femoral Resection

Insert the IM Rod into the femoral canal
to the level of the isthmus. Disengage the
Distal Femoral Jig from the Handle by
pushing on the V/V Indicator Cap and slide
the Jig toward the femur until the distal
plate contacts the distal femur. The jig may
be pinned temporarily using pin holes in
the distal resection plate.
Position the Distal Femoral Cutting Block
on the anterior femur by rotating it until
it is seated on the anterior condyles.

Distal Femoral Resection

Divergent Pin Hole

Secure the Cutting Block to the femur with
two Universal or Non-Headed Pins through
the holes marked with a center line. To
further adjust the distal resection depth
once the Distal Femoral Jig is removed,
use the distal or proximal pin holes, that
move the block 2 mm in either direction.
If necessary for additional stability, insert
a Universal or Non-Headed Pin through
one of the divergent pin holes on the
Cutting Block.

Removal of the Distal Femoral Jig

Pull Distally

Disengage the Distal Femoral Cutting
Block from the Outrigger Slide by pressing
the Red Cutting Block Clip. Pull the entire
instrument distally.

Cutting Block Clip

Distal Femoral Resection

Resect the distal femur.
Remove the Distal Femoral Cutting Block.
Depending on surgeon preference, the
Pins may be removed or left in place to
allow for a recut if required.

Tibial Alignment and Resection – Instrument Assembly

Complete
Assembly

Proximal Central
Marking

Right Tibial
Cutting Block

Tibial Jig Assembly
With the Height Adjustment Knob fully

Extramedullary Tibial Proximal Uprod

unscrewed on the Tibial Proximal Uprod,
attach the Tibial Distal Uprod to the
Proximal Uprod. Then attach the Tibial
Ankle Clamp to the Distal Uprod.
Assemble the appropriate Cutting Block
to the Tibial Proximal Uprod.

Posterior Slope Adjustment

Cutting Block Options
Height Adjustment Knob

Extramedullary Tibial
Ankle Clamp
Left Tibial Cutting Block

Indicator Line

A/P Adjustment
Mechanism

Right Tibial Cutting Block

A/P Ratchet

V/V Adjustment
Mechanism

Extramedullary Tibial
Distal Uprod
15

Symmetrical Cutting Block

Tibial Alignment and Resection

Pinch Lever

Set the desired tibial posterior slope prior to
attaching to the leg, which is indicated on the
Proximal Uprod, by using the two pinch levers on
the adjustment.

Height Adjustment Knob

Place the knee in 90 degrees of flexion. Place the Ankle
Clamp around the malleoli. Set Varus/Valgus rotation by
aligning the proximal central marking on the Tibial Cutting
Block with the medial one third of the tibial tubercle.
Position the Tibial Distal Uprod so that it is parallel with the
axis of the tibia using the A/P Ratchet at the ankle. An
approximation of this can be done by running 2 fingers

between the uprod and the anterior face of the tibia.

INFORMATION
For a posterior stabilized (PS) design, a 0-3 degree
posterior slope is recommended. For a cruciate retaining
(CR) design, match the patient slope up to 7 degrees.
Optional: Insert a Threaded Headed Pin through the
center of the vertical slot in the Cutting Block to aid
stability.

Tibial Alignment and Resection

On an average size tibia, the A/P adjustment mechanism
provides approximately 0 degrees of tibial slope when
the A/P adjustment is translated anteriorly until both
the Through-Slot and the Side Slot in the A/P Ratchet are
covered.

Through-Slot
A/P Ratchet
A/P Boss
Side Slot

V/V Adjustment

Use the Varus/Valgus Adjustment
Mechanism to align the Tibial Proximal
Uprod parallel to the long axis of the tibia.
For many patients, this involves translating
the V/V Adjustment Mechanism until the
second line from the lateral side of the
ankle clamp lines up with the indicator line.

Indicator Line

CAUTION

INFORMATION

When checking and setting the sagittal alignment,

In ankles with a large soft tissue envelope in which

be careful to prevent anterior slope. This could

the soft tissue prevents achieving 0 degrees of

happen if the A/P Boss on the Distal Uprod is

alignment at the neutral position, the Distal Uprod

translated too far towards the ankle, exposing the

can be moved posterior to reveal the Through-Slot

Through-Slot. Posterior slope adjustment is the

to achieve a 0 degree slope.

equivalent to using Cutting Blocks with slope built
into them.

Tibial Alignment and Resection

Stylus Attachment
Resection Knob
Attach the Adjustable Tibial Stylus
to the Cutting Block through the

Pointer

slot feature.

Foot

4 mm difference between
a Slotted and Non-Slotted
resection

Resection through the Slot

Resection on top of the Cutting Slot

If planning to resect through the slot, position the

If planning to resect on top of the Cutting Block, place

foot of the Stylus marked “slot” into the Slot Feature

the foot marked “non-slot” into the Slot Feature.

of the Cutting Block.

INFORMATION
Rotate the Resection Knob to set the resection level

The minimum composite thickness of the tibial implant

on the Stylus (0 to 10). Each number corresponds to

(4 mm base +5 mm insert) is 9 mm.

a resection amount in millimeters.
Rest the pointer of the Adjustable Tibial Stylus on
the lowest point of the tibial plateau. Then lock the
Height Adjustment Knob on the Proximal Uprod.

Tibial Alignment and Resection

After the height has been set, pin the block
through the holes marked by a center line
using two Universal Pins.

If necessary, remove the Stylus for better access,
ensuring that the Height Adjustment Knob is locked.
The resection level can be adjusted by using the distal
or proximal pin holes, which move the block 2 mm in
either direction. If desired, the Cutting Block can be
more securely fixed with an additional Universal or
Non-Headed Pin placed through the distal angled hole.
Distal Angled Hole

Temporary Fixation Pin Slot

Tibial Alignment and Resection

Optional: To assess long leg alignment, place
the Alignment Handle into the Slot Feature
of the Cutting Block, and insert the Alignment
Rod. Alignment can be checked by ensuring
that the Alignment Rod remains parallel with
the tibial axis.
In addition, a second Alignment Rod may be
inserted through the Alignment Handle in the
M/L plane to help ensure that the tibia is not
cut in Varus or Valgus.

Resect the tibia.

INFORMATION
Place retractors to protect the PCL and collateral
ligaments during tibial resection.

Extension Gap Assessment and Balancing

Spacer Base

Shim

Spacer Block

Posterior Stabilized

Cruciate Retaining

For the PS technique, connect the ATTUNE Knee System

For the CR technique, evaluate the CR extension gap

Spacer Base and desired Shim to the Spacer Block to

as described in the previous paragraph. To assess the

assess both the extension and flexion gaps. When the

CR flexion gap connect the CR Flexion Base and desired

ATTUNE Spacer Base is attached, both ends of the Spacer

Shim to one end of the Spacer Block. The CR Flexion

Block are equal thicknesses and can each be connected

Base compensates for the 1 mm difference in thickness

to a different Shim to allow successive evaluation of

of the posterior condyles of the CR implant.

multiple thicknesses. As an example, if the surgeon is
unsure as to whether the gap will correspond to a 5 mm

or 6 mm insert, the 5 mm Shim can be connected to one

Distal Condyle Thickness

end and the 6 mm Shim to the other.

Posterior Condyle Thickness

INFORMATION
The Spacer Block is designed to accommodate both

thicknesses. The labels on the Shims indicate the

CR and PS techniques. In the PS implant the distal and

thickness of the insert they represent when assembled

posterior condyles are the same thickness, resulting in

to the Spacer Block, and can be read off the top of the

no compensation required for extension and flexion

Shim when it is attached to the Spacer Block. Although

balancing. In the CR implant the posterior condyle is

any size Shim will assemble to the Spacer Block, the size

1 mm thinner than the distal condyles. The Spacer Block

5/6 Shim is recommended as it most closely matches the

connects to Shims on both ends to evaluate multiple

shape of the Spacer Block.

Extension Gap Assessment and Balancing

To check the extension gap, fully extend
the leg and place the appropriate end of
the Spacer Block between the two resected
surfaces. The Block should fit snugly in the
extension space. The extension gap should
be rectangular with the leg in full extension.
If the extension gap is not balanced, adjust
the angle of either the tibial or the femoral
cut, or perform appropriate soft-tissue
releases to achieve balance.
If desired, perform a gentle Varus/Valgus
stress test with the Spacer Block in place.
Typically 1 mm to 3 mm of opening both
medially and laterally is desirable.

If desired, the two piece Alignment Rod
can be inserted into the Spacer Block to
assess alignment.
The Spacer Block can also be used to assess
the flexion gap after resecting the posterior
femoral condyles.

Measured Femoral Sizing and Rotation

Measured Sizing and Rotation Guide
Size Locking Knob

Stylus

Anterior Down Pin Hole
Anterior Down Pin Hole
Femoral Size Markings

Femoral Rotation Lever
Posterior Up Pin Hole

Fixation Pin Holes
Posterior Up Pin Hole

Anatomic Reference Mark

Feet

Rotation Markings

INFORMATION
Choosing the anterior down pin holes will provide a

Conversely, choosing the posterior up pin holes will

fixed anterior reference with a constant anterior cut,

provide a fixed posterior reference with a fixed posterior

regardless of the size of the A/P Chamfer Block. All

cut. All variability in bone cuts from size to size will

variability in bone cuts from size to size will occur on

occur on the anterior cut.

the posterior cut.
The Measured Sizer instrument is named to indicate its use for a Measured Resection surgical philosophy and is not
a measurement device.

Measured Femoral Sizing and Rotation

Placement of Sizing Guide
Whiteside's Line
Mark the A/P Axis (Whiteside's line)
and/or the epicondylar axis on the
resected distal femur.

Epicondylar Axis

Threaded Headed Pin through
the Fixation Hole

Place the Measured Sizing and Rotation Guide against the resected
surface of the distal femur with the posterior feet of the guide
contacting the posterior condyles. If desired, secure the Guide with
a Threaded Headed Pin through the fixation hole.

Measured Femoral Sizing and Rotation
Size Locking Knob
!

Slide the anterior section down and
position the Stylus so the tip just contacts
the desired point on the anterior femur.

Adjust the superior-inferior position of the scale to indicate
the proper femoral size. The position of the Stylus will then
be located near the exit point of the Saw Blade. Read the
scale from the distal side of the Size Locking Knob.

The line through the center of the Anterior
Down Pin Holes indicates the size of the
femur. Lock the size position by twisting
the Size Locking Knob.

Anterior Down Pin Holes
indicating Size 5

CAUTION
Be very careful not to apply a large force when
contacting the anterior femur with the Stylus,
avoiding excessive deflection of Stylus which
may bias the sizing.

Measured Femoral Sizing and Rotation
Squeeze the Lever and
simultaneously rotate

Adjust the degree of external rotation to be
parallel the epicondylar axis and perpendicular
to Whiteside's line by squeezing the Femoral
Rotation Lever and rotating the anterior section
while holding the feet of the device against the
posterior condyles.

Whiteside's Line

Epicondylar Axis
Right Side

Left Side

The rotation markings indicate the degree of external femoral
rotation with reference to the posterior condyles

Pin Insertion
Insert Universal or Non-Headed Pins through the
top pin holes for anterior down referencing
OR
Insert Universal or Non-Headed Pins through the
bottom pin holes for posterior up referencing
(For further information see page 23).

Measured Femoral Sizing and Rotation

Removal of Sizer

1.
3.

Threaded Headed Pin

1. Remove the Threaded Headed Pin, if utilized.
2. Release the Knob by rotating counterclockwise.
3. The Stylus is loosened, then pushed forward on the anterior
face of the femur so that it is no longer contacting the bone
surface (as the anterior surface slopes downward). The Sizer is
pulled off the femur and the 2 components removed together.
4. Remove the Sizing/Rotation Guide, leaving the Universal or
Non-Headed Pins in the distal femur.

Balanced Femoral Sizing and Rotation

Balanced Sizing/Rotation Guide Assembly

To accommodate differences in the flexion gap assessment
between the CR and PS Femoral Implants, two different feet are
available. Attach the appropriate CR or PS Balanced Sizer Foot to
the Balanced Sizing/Rotation Guide.

Tensioning Knob

Locking Knob
Stylus

Sizing Scale
Pin Holes
Insert Thickness Scale
IM Rod Hole

Foot

Balanced Femoral Sizing and Rotation

Balanced Sizing and Rotation Guide
The Balanced Sizer performs several key
functions:
1. Sizes the femur
2. Sets rotation of the femur based on
ligament tension
3. Enables assessment of the flexion gap in
comparison to the previously determined
extension gap
Before using the Balanced Sizer, measure

Attach the IM Rod Handle to the Balanced

the extension gap using the Spacer Block

Sizer IM Rod and insert the Rod into the

as outlined on page 22. After making the

intramedullary canal.

primary cuts and measuring the extension
gap, record the insert thickness that
corresponds to the extension gap for
future reference.

Use the handle as a Slap Hammer to secure

INFORMATION

the Tapered Plug and stabilize the IM Rod.

The Balanced Sizer technique is anterior

The Tapered Plug may not fit flush against

referencing only.

the bone, but should be tight.

The Tapered Plug may not fit flush against
the bone, but should be tight.

Balanced Femoral Sizing and Rotation

Sizing the Femur

1. Slide the main body and foot of the Balanced Sizer onto the IM
Rod with the knee flexed at 90 degrees, ensuring that the feet
clear the posterior condlyes.
2. Turn the Tensioning Knob in a counterclockwise (SZ) direction
until the Sizer Foot contacts the posterior femoral condyles.
Once the sizer foot contacts the posterior femoral condyles the
sizer should not be able to rotate about the IM Rod.

Slide the Sizing Guide and Stylus over the
main body of the Balanced Sizer until the
Stylus touches the anterior femur.

INFORMATION
Once the Foot of the Balanced Sizer have contacted
the posterior femoral condyles, be careful not to
excessively rotate the Tensioning Knob in the SZ
direction as this could result in disassembling the
device.

Locking Knob should be loose
at this point of the process

Balanced Femoral Sizing and Rotation

Confirm that the Guide is firmly placed

Sizer fits against
distal femoral cut surface

against the distal femoral cut with the knee
flexed at 90 degrees.

Stylus tip touches
the sulcus

Adjust the superior-inferior position of the
Stylus to indicate the proper femoral size.
The position of the Stylus will then be
located near the exit point of the Saw Blade.
Foot of Sizer
contact posterior
condyles of femur

Size 4
!

Then read the femoral size at the “SZ” line
of the Guide.

CAUTION
Be very careful not to apply a large force when
contacting the anterior femur with the Stylus.
At this point in the procedure do NOT lock the
assembly by turning the Locking Knob. The Locking
Knob should only be turned to lock the assembly
after completion of balancing and in preparation
of pin placement.

Balanced Femoral Sizing and Rotation

Setting Femoral Rotation
Turn the Tensioning Knob in a clockwise (MM)
direction until the gap in flexion (Insert Thickness
Measurement) matches the previously measured
extension gap.

8 mm tibial insert thickness
for a size 4 femoral component
To determine the tibial insert
thickness read the insert thickness
scale across from the previously
determined femoral size
indication. e.g. This image
indicates an 8 mm Tibial Insert for
a size 4 Femoral component.

Balanced Femoral Sizing and Rotation
Check for lift-off
!

To assess the tension, hold the tibia firmly and use
the Tensioning Knob to apply a Varus/Valgus stress
whilst observing lift off between the Sizer Foot and
the tibial cut.

If further tension is required, turn the Tensioning Knob in a
clockwise direction until the next thickness of insert is reached
and conduct a further assessment of the ligaments using a Varus/
Valgus stress test. If the predicted insert thickness in flexion is not
matching the previously measured extension thickness, then the
surgeon may need to consider moving the femoral component
position by 1.5 mm in an anterior or posterior direction, or upsizing
or downsizing the femoral component, using the 4-in-1 Cutting
Block, as described on page 35. Refer to page 67 for further
gap balancing information.

CAUTION
Over-rotation of the lateral condyle in the anterior
direction could result in excessive femoral component
external rotation and could be an indication of
over-tightening.

Balanced Femoral Sizing and Rotation

Lock the assembly in place by rotating the Locking
Knob clockwise. Insert Universal Pins into the Pin
Holes on each side of the Sizing Scale.
Insert Pins

Remove the Balanced Sizer. First unlock the Locking
Knob and release the tension by turning the
Tensioning Knob in a counterclockwise direction.
Attach the Rod Handle and remove the IM Rod with
the Tapered Plug, engage the Tapered Plug with the
guide to remove it from the bone.

Femoral Preparation

4-in-1 Cutting Block
Sulcus window as a visual reference
for sulcus placement
+1.5 mm Hole
Center Line Hole
-1.5 mm Hole

Anterior Down
Referencing Pin Holes

Posterior Up
Referencing Pin Holes
Narrow Size
Reference Cutout

Modular Posterior Saw Capture
to aid balancing flexion
space with Spacer Blocks

The cutout indicates the width
of the narrow size of implants

INFORMATION
The ATTUNE Knee System femoral components increase

This creates the intraoperative flexibility to position the

in size by a consistent 3 mm in the A/P direction. The

femoral component based on the surgeon’s assessment of

Intuition A/P Cutting Blocks allow the surgeon to adjust

the flexion gap and the desired posterior condylar offset.

the A/P position of the femoral component by 1.5 mm in

See page 67 for more information on gap balancing.

either direction.

Femoral Preparation

Alignment Slots

A/P and Chamfer Cuts
Select the A/P Chamfer Block that matches
the femur size. Place the Block over the
two anterior or posterior Universal or
Non-Headed Pins through the pin holes
marked with a center line.

The flexion space can be checked by
using a Spacer Block placed below the
A/P Chamfer Block with the Modular
Posterior Saw Capture removed.

INFORMATION
When using the anterior offset pin holes, changing the

Then remove the anterior reference pins. This enables the

size of the femoral component will alter the posterior

femoral implant size to be adjusted without altering the

femoral condyle resection.

flexion gap.

To evaluate femoral size adjustments without altering

Alternatively, the Block can be moved 1.5 mm up or down

the posterior femoral cut, place the A/P Chamfer Block

(one hole location) to adjust the flexion gap, if necessary.

onto the anterior Universal Pins and insert two additional
pins through the posterior-up holes on the Block.
36

Femoral Preparation

Angel Wing
Use the Angel Wing to confirm the location
of the cut and the degree of rotation. The
Block can also be used at this stage to assess
the M/L width of the implant size for both
the standard or narrow sizes.

Insert Threaded Headed Pins into the
divergent pin holes on the medial and
lateral aspects of the A/P Chamfer Block.

Femoral Preparation

Recommended: Re-attach the appropriate size

Place Retractors to protect the medial and lateral

Modular Posterior Saw Capture to the A/P Chamfer

collateral ligaments and the popliteal tendon.

Block to provide for capture guidance on all cuts.

Then resect the anterior and posterior femur.

Remove the Universal or Non-Headed Pins and cut the anterior and posterior chamfers.
Remove the Threaded Headed Pins and the A/P Chamfer Block.

INFORMATION
The posterior Saw Captures are open medially and laterally
to accommodate complete saw cuts. To reduce the risk of
inadvertent Saw Blade kickout, point the Blade slightly
toward the midline before starting the Saw.

Posterior Condyle Preparation
Removal of Excess Bone

Reference Window
Dotted lines indicate the outer edges of the final component

Cutouts indicate narrow size
For optimal stability, place Base Pins as shown

To avoid impingement in flexion, remove any excess bone
between the posterior tibial implant and the posterior
femoral condyles in flexion. To aid in osteophyte and excess
bone removal, select the Femoral Finishing Guide that
corresponds to the femoral trial component size. Push the
instrument onto the resected distal femur and position
mediolaterally, using the lateral anterior profile of the
instrument as a guide. The inner surface of the windows
represents the anterior medial aspect of the implant and
the outside profile of the anterior face represents the
anterior lateral aspect of the implant.
Fix the instrument flush to the distal cut using Base Pins.

INFORMATION
The cutouts on the sides of the Femoral Finishing Guide
show where the outer edge of the narrow component
is located. If there is no cutout, a narrow component
is not available for that size. Narrow components are

Base Pin

available for sizes 3, 4, 5 and 6.

Posterior Condyle Preparation

Removal of Excess Bone (Cont.)
With the Femoral Finishing Guide in place,
verify that any excess bone or residual

Curved Osteotome

osteophytes in the posterior recesses have
been removed. If not, use a Curved
Osteotome or Gouge to remove any
remaining bone that can be seen beyond
the end of the Femoral Finishing Guide feet.
Always work carefully under direct vision
to avoid damage to the neurovascular
structures in the popliteal fossa.

CR Sulcus Preparation
When implanting an ATTUNE Knee System CR
component, use the Femoral Finishing Guide
to perform the sulcus cut. Using the Sulcus Cut
Ramp as a guide, remove bone from the sulcus
with the Rasp, a 0.5 inch Saw or Osteotome.
Then remove the Femoral Finishing Guide.

Sulcus Cut Ramp

Femoral Resection – PS Notch Cuts

Reference Window
Dotted lines indicate the outer edges of the final component

The tongue of the Notch Guide is extended to
provide a long cutting surface for an 18 degree cut
When implanting an ATTUNE Knee System PS component,
use the Notch Guide to perform the notch cut. The profile of
the Notch Guide provides anterior and distal references to
the width of the implant. In addition, windows in the Notch
Guide provide additional reference.
The inner surface of the windows represents the anterior medial
For optimal stability, place
Threaded Headed Pins as shown

aspect of the implant and the outside profile of the Notch Guide
represents the anterior lateral aspect of the implant. The
references are designed to confirm optimal component size and
position. The tongue of the Notch Guide is extended to provide
a long cutting surface for an 18 degree cut.
Position the Notch Guide on the resected anterior and distal
surfaces of the femur as far laterally as possible while
assuring that the lateral border of the implant does not
overhang the lateral femoral cortex. Pin the Guide in place
using the Threaded Headed Pins.

INFORMATION
The cutouts on the sides of the Notch Guide show where
the outer edge of the narrow component is located. If
there is no cutout, a narrow component is not available
for that size. Narrow components are available for sizes
3, 4, 5 and 6.

Femoral Resection – PS Notch Cuts

Perform the notch cut.

18 Degree Cut
Reference Window
Width Reference

Narrow Size
Reference Cutout

CAUTION
When completing the notch cut, be careful to avoid
excessive angulation of the Saw Blade or penetration
past the posterior femoral cortex to avoid injury to
the neurovascular structures.
Avoid undercutting the condyles.

Trial Reduction

Position the appropriate Femoral
Trial onto the femur by hand. Use

Color Coded
Marking

the Femoral Impactor to impact
the trial as necessary.

Narrow Size Reference Cutout

Femoral Component Indicators
CR
PS

INFORMATION

If the trial is not seating properly, the bone cuts may need

The cutouts on the sides of the Femoral Trial show

to be rechecked. The Femoral Trial should be fully seated

where the outer edge of the narrow component is

prior to joint reduction.

located. If there is no cutout, a narrow component is
not available for that size. Narrow components are
available for sizes 3, 4, 5 and 6.

Trial Components

Tibial Trial
Attach the Alignment Handle to the appropriate

Non-Spiked Evaluation Bullet

size Tibial Base Trial and place onto the resected
tibial surface. Assess the position of the base to

Spiked Evaluation Bullet

maximize tibial coverage while avoiding overhang.
The rotation of the Tibial Base Trial is typically
centered on the junction between the medial and
central third of the tibial tubercle.

Central Mark

Fixed Bearing
For fixed bearing tibial components, insert the Non-Spiked Evaluation
Bullet into the cutout of the Base Trial by hand. The Non-Spiked
Evaluation Bullet is used when allowing normal internal/external
rotation of the tibial component during a range of motion to dictate
the optimal placement of the tibial base. The bone can be marked for
Base Trial orientation reference.

INFORMATION
Tibial components can be trialed before preparing the
tibia.

Trial Components

CR Articulation Surface

PS Articulation Surface

Shim

Select the Tibial Articulation Surface Trial that matches

14 mm and 16 mm for CR and PS, and in addition 18 mm

the femoral size and style (CR or PS fixed bearing), and

for PS, for core sizes 3-8). The thickness markings on the

attach the corresponding size Shim of the appropriate

insert trials and the final insert implant indicate the

thickness (5 mm, 6 mm, 7 mm, 8 mm, 10 mm, 12 mm,

insert thickness without the base thickness included.

Fixed Bearing

Balseal Damage

Ensure that the Articulation Surface Trial and Shim are

securely engaged, as these two components make up
the Insert Trial. Attach the assembly into the Tibial
Base Trial.
Check for Balseal damage. If damage is observed,
replace the damaged component.

Trial Components

Remove the Alignment Handle from the Tibial Base Trial and,
with the trial prosthesis in place, extend the knee carefully, noting
the anteroposterior and mediolateral stability, and the overall
alignment in the A/P and M/L planes. If there is any indication
of instability, use the next thicker Shim and repeat the check.
Select the trial assembly that provides the greatest stability in
flexion while still allowing full extension. Verify that the posterior
femoral condyles are sufficiently prepared to prevent impingement
on the tibial insert in deep flexion.

Re-attach the Alignment Handle to the Tibial
Base Trial and then attach the two-part
Alignment Rod to the Alignment Handle and
confirm the overall alignment. For a fixed
bearing component, mark the position of the
trial component on the anterior tibial cortex.

Trial Components

Fully flex the knee, and remove the Insert Trial.
The Trial Extractor can be used to aid in removal
of Insert Trials.

Trial Extractor

Insert the Trial Extractor between the Tibial Base
Trial and the Shim and lever the handle towards
the foot in order to remove the Insert Trial.

Patella/Femoral Drill

Femoral Lug Hole Preparation
For implant sizes 3-10, use the Patella/Femoral
Drill to drill through the appropriate holes.
For implant sizes 1-2, use the size 1-2 Femur Drill.

INFORMATION
Do not insert the Trial Extractor between the Shim and the articulation
surface to prevent damage to the connection feature.
The Trial Extractor can also be used to remove the Femoral Trial.
When removing the Tibial Trials with the Trial Extractor, avoid engaging
the Keel Punch to prevent damage to the Trial Extractor.

Tibial Preparation

Re-attach the Handle to the Tibial Base Trial and re-insert
it on the resected tibial surface, (aligning it with the
mark on the bone for a Fixed Bearing Tibial Construct).
Base Pins

Attach the Tibial Drill Tower to the Tibial Base Trial by
inserting the spikes on the underside of the Tower
through the two inside holes on the anterior aspect of
the base trial. The spikes provide fixation for both the
Drill Tower and the Base Trial. If additional fixation is
desired, place Base Pins through the two outside holes
on the anterior aspect of the Base Trial.

Use the Tibial Drill to ream the tibia to where the line marked on the
side of the Drill aligns to the top surface of the tower. The Line marking
corresponds to the Tibial Base size. Bone debris from drilling could
prevent the Keel Punch from seating completely in the Base Trial.
To prevent this, flush out the cavity after drilling.

CAUTION
Care should be taken not to protrude through the
medial tibial cortex if using the medial Base Pin.
Care should be taken not to overdrill. An optional
Drill Stop is available.

Tibial Preparation

Keel Punch

Attach the correct size Keel Punch to the Impaction Handle, and
insert the assembly into the Tibial Drill Tower. Impact the assembly
into the cancellous bone until the Keel Punch is seated flush on the
Tibial Base Trial.
Use the anterior window in the tower to monitor the progress of
the Keel Punch while impacting.

When the Keel Punch is fully seated,
the Impaction Handle will automatically
disengage from the Keel Punch, allowing
the Impaction Handle and the Tibial Drill
Tower to be removed together.

Integrated Insertion
and Removal

INFORMATION
Optional: If desired, perform a final trial reduction
by inserting the appropriate trial components and
repeating the previous trial evaluation.

Patella Resection and Preparation
– Instrument Assembly
Patella Resection Guide

Clamp Teeth

Height Gauge sets Resection Depth
to 9.5 mm and can be rotated to find
the highest point on the Patella or to
be moved out of the way

Saw Slot

Release button unclamps the
Resection Guide from the bone

Clamp Trigger

Patella Drill Trials

Patella
Drill Trial
Trial Handle

Assemble by inserting the Trial Handle into the
slot on the Drill Trial until it clicks into place

Patella Resection and Preparation
– Instrument Assembly
Patella Modular Clamp

Drill Trial

Clamp Ring

Silicone base protects the implant
surface during cement pressurization

Clamp Connection Post attaches to either the Drill Trials
or Clamp Ring with a snap-on mechanism

Release button locks and
unlocks clamping force

INFORMATION
The patella instrumentation is designed for a medial
approach only.

The clamp and trial handle are designed for a medial
approach only. The Resection Guide and Drill Trials
(used as stand alone without the clamp) can be used
for a medial or lateral approach.

Patella Resection

Use the Caliper to estimate the thickness of the patella and evaluate the
level of bone resection. The Height Gauge on the Patella Resection Guide
accounts for a resection of 9.5 mm of bone, which is the average thickness
of the ATTUNE Knee System Patella components.

Place the leg in extension and evert the patella.
Position the Patella Resection Guide so the Height Gauge is
against the articular surface of the patella. Align the serrated
jaws at the medial and lateral margins of the articular surface.
Engage the largest tooth on the lateral side then engage the
largest tooth on the opposite side to temporarily secure the
clamp while allowing for rotation of the patella until the
inferior and superior orientation is achieved and clamp fully.

CAUTION

INFORMATION

If the patellar thickness is less than 21.5 mm, the

The resection progresses from the medial

thickness of the bone remaining after resection

chondro-osseous junction to the lateral

would be less than 12 mm and resecting less bone

chondro-osseous junction.

should be considered.
If less resection is required, the Patella Guide Shim
is available which reduces the depth of the resection
to 7.5 mm.

Patella Resection

Perform the resection using an Oscillating
Saw through the Saw Capture.

Patella Wafer

If desired, place a Patella Wafer on the

INFORMATION

resected surface by hand to protect the
When resecting the patella, care should be taken

patellar bone bed.

to avoid Saw Blade excursion into the Femoral
Trials or Implants.

Patella Preparation

Patella Implant Options

Anatomic Patella

Medialized Dome Patella

Patella Size Chart
Size

Thickness

8.5 mm

9 mm

9.5 mm

10 mm

10.5 mm

Two patella options are available; the Medialized Dome Patella or
the Anatomic Patella.
The Anatomic Patella is designed to be conforming with the
femoral component and has a built in range of +/- 15 degrees
freedom of rotation from its optimal position. Therefore, accurate
alignment of the Patella Drill Trial is important for proper patella
placement and tracking.
The following steps will aid in accurate alignment of both patella
designs, but is particularly critical for the Anatomic Patella.

Patella Preparation

Patella Drill Trialing
If used, remove the Patella Wafer from the patella. Place the Patella
Drill Trial on the resected patella to assess bone coverage. Select the
correct size of Patella Drill Trial for maximum patella bone coverage.
Verify the medial lateral location of the patella implant apex relative
to the native anatomy ridge.

INFORMATION
Optional Technique:
Prior to resecting the patella a small hole can be drilled

This hole can be visually aligned with the pre-drilled

through the apex of the native patella bone (1-2 mm

hole on the resected patella surface to aid in anatomic

deeper than the intended amount of resection). Once

placement of the trial.

the patella has been resected the remainder of the hole
will be present on the resected bone surface. The Drill
Trial has a small hole through the center of the apex,
representing the peak of the patella implant.
55

Patella Preparation

Patella Drill Trialing
Press the trial onto the bone manually or with the Patella
Modular Clamp and Clamp Ring to engage spikes.

Large central spike

The Drill Trials have one larger central spike to allow
engagement of only the central spike so that the Drill Trial
may be rotated about the central axis to aid in assessment
of its optimal position prior to being fully seated on bone.

The Trial Handle may be used to aid in determining
optimal position.
Reduce the patella with the Drill Trial in place and
Trial Handle attached. When properly aligned, the
Trial Handle should be perpendicular to the long axis
of the leg and parallel to the prosthetic joint line.
If the Drill Trial/Trial Handle appears to be misaligned
to the long axis or joint line, the trial should be
removed from the patella and reset until proper
alignment is achieved.

Patella Preparation

Use the Patella Modular Clamp to secure the Drill Trial if
desired. Drill the holes using the Patella/Femoral Lug Drill.
!

CAUTION
If the surgeon is not satisfied with alignment or
tracking of the Anatomic Patella Trial after drilling
the peg holes, it is recommended to use a Medialized
Dome Patella.

Tibial Base Implantation

Cementing Technique
!

During cementing of implants, movement of the components
should be minimized while the cement is curing.
Prepare the sclerotic bone to ensure a continuous cement mantle
with good cement interdigitation of 2 mm - 4 mm. This can be
done by drilling holes and cleansing the bone with Pulsatile
Lavage. Pack residual small cavity bone defects with cancellous
autograft, allograft, or synthetic bone substitutes.

Base Protector

Place a layer of cement on the bone,
the implant, or both.

CAUTION
Blood lamination can reduce the mechanical properties
of the cement; therefore, it is vital to choose cement
that reaches its working phase quickly.

Tibial Base Implantation

Carefully insert the Tibial Base, avoiding
malrotation. Select the fixed bearing
Tibial Impactor.

FB Tibial Impactor

CAUTION
To prevent damage to the bearing surface, do not

With the base inserted, impact it with

remove the Base Protector before impacting the base.

several blows from a Mallet to the top of
the Impactor. Then use a Curette to remove
all extruded cement.

Femoral Component Implantation
Rotate thumb wheel to bias
the grip arms outward

Rotate side knob
clockwise to lock
Place the femoral component onto the

Grip Arm

bone by hand or, if preferred, use the

Impaction Shoe

Femoral Introducer.
Position the femoral component on the
Introducer by rotating the red Central
Thumb Wheel on the Introducer to move
Grip Arm

the Grip Arms outward. Then push the
femoral component against the impaction
shoes, and rotate the Central Thumb

Impaction Shoe

Wheel to move the Grip Arms inward so
that the arms engage in the slots on the
femoral component. Rotate the Side Knob
clockwise to lock and secure the implant.

Begin inserting the femoral component by
engaging the Femoral Lugs in the lug holes
of the distal femur, and deliver several
Mallet blows to the Introducer.
To release the Femoral Introducer, rotate
the Side Knob counterclockwise and rotate
the red Central Thumb Wheel to move the
Grip Arms outward.

Femoral Component Implantation

Condylar Impaction

Femoral Impactor

For final femoral component impaction,
attach the Impaction Handle to the Femoral
Impactor head.

Notch Impaction

Use a combination of condylar and notch
impaction to seat the femoral component.
Then use a Curette to remove all extruded
cement.

INFORMATION
The Femoral Introducer is not designed for nor
intended to be used for femoral component removal.

Tibial Insert Implantation
A trial reduction may be performed using Insert Trials.

Fixed Bearing

For fixed bearing components, place the Insert Trial on
the Tibial Base. Verify that the Insert Trial does not tilt
up off the front of the base during the range of motion
test. This could indicate that the PCL is too tight.
Remove loose fragments or particulates from the Final
Tibial Base.

For fixed bearing tibial components, angle the Tibial
Insert posteriorly and slide the posterior tabs into the
posterior undercuts of the Tibial Base.

Insert slides back
and then down

CAUTION
The Base Protector should be kept in place during
trialing, then it MUST be removed before assembling
the final Tibial Insert.

Tibial Insert Implantation

Fixed Bearing Insert Impactor

60˚

The Fixed Bearing Tibial Insert is impacted into place on the Tibial
Base, using the Fixed Bearing Insert Impactor.
Position the Impactor at approximately 60 degrees on the insert so
that the notch rests on the anterior edge of the center of the insert.
Use a Mallet to strike the Fixed Bearing Insert Impactor. Confirm
seating by circumferential inspection.

Final Patella Preparation

Apply cement to the patella implant. Thoroughly clean the
cut surface of the patella with pulsatile lavage. Apply cement
to the surface of the patella and insert the component.

Connect the Clamp Ring to the Patella Modular Clamp.

Patella Component Implantation

The Clamp Ring is designed to fully seat and stabilize
the implant as the cement polymerizes.
Center the Clamp Ring over the articular surface
of the implant and the metal backing plate against
the anterior cortex of the patella, avoiding skin
entrapment.
Engage the Patella Clamp Handle to firmly hold the
Patella Implant until polymerization is complete.
Remove all extruded cement with a Curette.
Release the Clamp by unlocking the Locking-Switch
on the handle and slightly squeezing the Clamp
Handles to disengage the locking mechanism.

Reduce the patella.

Closure

Close the knee in layers using the surgeon’s
preferred technique.

Stable Flexion

Tight Flexion

Loose Flexion

Flexion/Extension Gap Chart

Loose Extension

Tight Extension

Stable Extension

Cause:
Flexion and extension gaps are too large

Cause:
Flexion gap is larger than the extension gap

Cause:
Flexion gap is larger than extension gap

Possible Solution(s):
• Thicker tibial insert

Possible Solution(s):
• Recut distal femur and use thicker insert
• Posterior capsular release
• Posteriorise the femoral component
by 1.5 mm

Possible Solution(s):
•D
ecrease the tibial slope and use a
thicker tibial insert
•R
ecut the distal femur and use a
thicker tibial insert
• L arger femoral component
• P osteriorise the femoral component
by 1.5 mm

Cause:
Extension gap is larger than flexion gap

Cause:
Flexion and extension gaps are too small

Cause:
Flexion gap is too small

Possible Solution(s):
• Check for osteophytes
• Downsize femoral component and
use thicker insert
• Increase tibial slope
• Recess PCL off of femur or tibia

Possible Solution(s):
• Thinner tibial insert
• Resect additional tibia

Possible Solution(s):
• Check for osteophytes
• Downsize femoral component
•A
nteriorize the femoral component
by 1.5 mm
• Increase tibial slope
• Recess PCL off of femur or tibia

Cause:
Extension gap is too large

Cause:
Extension gap is too small

Cause:
Balanced gaps

Possible Solution(s):
• Downsize femoral component and
increase insert thickness
• Increase tibial slope and use thicker
tibial insert

Possible Solution(s):
• Recut distal femur
• Posterior capsular release
• Larger femoral component and
thinner insert

Possible Solution(s):
• No solution required

Compatibility Data

SIZE
SZ
Pink
Dark Blue
Grey
Black
Green
Yellow
Light Blue
Red
Purple
Brown

1
2
3/3N
4/4N
5/5N
6/6N
7
8
9
10

1
2
3
4
5
6
7
8
9
10

1
1
1

2
2
2
2

3
3
3
3
3

4
4
4
4
4

5
5
5
5
5

29
29
29
6
6
6
6
6

7
7
7
7
7

8
8
8
8
8

9
9 10
9 10
9 10

32
32
32
32
32
32

35
35
35
35
35
35
35
35

38
38
38
38
38
38
38
38
38
38

41
41
41
41
41
41
41
41
41
41

Symbols on Surgical Instruments

Some of the instruments have markings on them for guidance.
The interpretation of these markings is as detailed in the table below.

Symbol or Text

Definition

Symbol or Text

Definition

Cleaning position here

Lateral

Dismantle for cleaning

Medial

Unlock

Left Lateral

Lock

Right Lateral

Left

SULCUS

Sulcus

Right

FLEXION

Flexion

LEFT

Left

EXTENSION

Extension

RIGHT

Right

Size

Attune Cruciate Retaining Implant

TIB

Tibia

Attune Posterior Stabilised Implant

Refer to Accompanying Documents

Fixed Bearing

DEG

Degrees

ATTUNE™ KNEE SYSTEM FIXED BEARING KNEE

IMPORTANT

NOTE:

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.

DePuy Orthopaedics' 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.

INTENDED USE

CAUTION:

Total knee arthroplasty is intended to provide increased patient mobility and reduced
pain by replacing the damaged knee joint articulation in patients where there is
evidence of sufficient sound bone to seat and support the components. Total knee
replacement may be considered for younger patients if, in the opinion of the surgeon,
an unequivocal indication for total knee replacement outweighs the risks associated
with the age of the patient, and if limited demands regarding activity and knee
joint loading can be assured. This includes severely crippled patients with multiple
joint involvement for whom a gain in knee mobility may lead to an expectation of
significant improvement in the quality of their lives.

The following conditions, singularly or concurrently, tend to impose severe loading on
the affected extremity thereby placing the patient at higher risk of failure of the knee
replacement:
1. Obesity or excessive patient weight.
2. Manual labor.
3. Active sports participation.
4. High levels of patient activity.

INDICATIONS

5. Likelihood of falls.

Candidates for total knee replacement include patients with a severely painful and/
or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis,
rheumatoid arthritis, or a failed previous implant.

6. Alcohol or drug addiction.
7. Other disabilities, as appropriate.
In addition to the above, the following physical conditions, singularly or concurrently,
tend to adversely affect the fixation of knee replacement implants:

CONTRAINDICATIONS
The following conditions are contraindications for total knee replacement:

1. Marked osteoporosis or poor bone stock.

1. Active local or systemic infection.

2. Metabolic disorders or systemic pharmacological treatments leading to progressive
deterioration of solid bone support for the implant (e.g., diabetes mellitus, steroid
therapies, immunosuppressive therapies, etc.).

2. Loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular
deficiency in the affected limb in sufficient degree to render the procedure
unjustifiable (e.g., absence of musculoligamentous supporting structures, joint
neuropathy).

3. History of general or local infections.
4. Severe deformities leading to impaired fixation or improper positioning of the
implant.

3. Severe instability secondary to advanced loss of osteochondral structure or the
absence of collateral ligament integrity.

5. Tumors of the supporting bone structures.
NOTE:

6. Allergic reactions to implant materials (e.g. bone cement, metal, polyethylene).

Diabetes, at present, has not been established as a contraindication. However,
because of the increased risk for complications such as infection, slow wound healing,
etc., the physician should carefully consider the advisability of knee replacement in the
severely diabetic patient.

7. Tissue reactions to implant corrosion or implant wear debris.
8. Disabilities of other joints (i.e., hips or ankles).
A higher incidence of implant failure has been reported in paraplegics and in patients
with cerebral palsy or Parkinson’s Disease.

WARNINGS AND PRECAUTIONS

WHEN THE SURGEON DETERMINES THAT KNEE REPLACEMENT IS THE BEST
MEDICAL OPTION AVAILABLE AND DECIDES TO USE THIS PROSTHESIS IN A
PATIENT WHO HAS ANY OF THE ABOVE CONDITIONS OR WHO IS SIMPLY
YOUNG AND ACTIVE, IT IS IMPERATIVE THAT THE PATIENT BE INSTRUCTED
ABOUT THE STRENGTH LIMITATIONS OF THE MATERIALS USED IN THE DEVICE
AND FOR FIXATION AND THE RESULTANT NEED TO SUBSTANTIALLY REDUCE
OR ELIMINATE ANY OF THE ABOVE CONDITIONS.

CAUTION:
• Tibial insert size should be the same size as the selected femoral component size.
Tibial inserts should be within 2 sizes of the tibial base.
• Patella component sizes 38mm and 41mm may be used with all femoral
component sizes. Patella component size 29mm may only be used with femoral
component sizes 1 through 3. Patella component size 32mm may only be used
with femoral component sizes 1 through 6. Patella component size 35mm may
only be used with femoral component sizes 1 through 8.

The surgical and postoperative management of the patient must be carried out with
due consideration for all existing conditions. Mental attitudes or disorders resulting in
a patient's failure to adhere to the surgeon's orders may delay postoperative recovery
and/or increase the risk of adverse effects including implant or implant fixation failure.

• Implants and trial components from different manufacturers or implant systems
should never be used together.

Excessive physical activity or trauma to the replaced joint may contribute to premature
failure of the knee replacement by causing a change in position, fracture, and/or wear
of the implants. The functional life expectancy of prosthetic knee implants is, at
present, not clearly established. The patient should be informed that factors such
as weight and activity levels may significantly affect wear.

• Knee prosthesis components should never be reimplanted. Even though the
implant appears undamaged, the implant may have developed microscopic
imperfections which could lead to failure.
• Always use a trial prosthesis for trial purposes. Trials should not be assembled
with any components intended for permanent implantation. Trials must have the
same configuration size, as the corresponding components to be permanently
implanted.
• Do not alter or modify implants in any way.
• Avoid drilling multiple pin holes in the proximal tibia which may affect the
compressive strength of the tibia.
• When used with multiple components of a total knee replacement system, the MR
compatibility and safety of the entire system of implants has not been evaluated
and the entire system of implants has not been tested together for heating or
migration in the MR environment. The risks of exposure to MR include heating
and/or displacement of a metallic implant. Image artifacts including dead zones
and distortion may occur, especially in the immediate area around the implant,
requiring optimization of imaging parameters. In line with the recommendations of
the American College of Radiology, DePuy Orthopaedics, Inc. recommends that a
professional familiar with the specific MRI apparatus to be used, assess the patient
prior to any MRI examination or therapy.

DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581-0988
USA
Tel: +1 (800) 366 8143

0086

0M0000
0612-09-512 Rev 1

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