Global Unite Anatomic Platform Shoulder System ST

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GLOBAL UNITE
ANATOMIC
®

Platform Shoulder System

SURGICAL TECHNIQUE

®

Introducing the GLOBAL® UNITE® Platform Shoulder Arthroplasty System, a modular shoulder system that provides
surgeons principled adaptability within the operating room to restore valuable biomechanical function.
Every shoulder procedure provides unique challenges to the surgeon. That is why DePuy Synthes Joint Reconstruction*
created the GLOBAL UNITE System, a next generation platform system. The modular proximal bodies allow the surgeon
to restore proper joint height and anatomic alignment utilizing a streamlined surgical procedure.
In the event that the GLOBAL UNITE System requires conversion to a reverse shoulder, it does so by implementing the
reverse shoulder principles described by Professor Paul Grammont. Removal of the proximal body allows the epiphysis to
attach to a well-fixed distal stem within the humerus at the proper height and version to optimize deltoid function, thus
allowing the deltoid to compensate for the deficient rotator cuff muscles.
The GLOBAL UNITE System truly provides the surgeon Principled Adaptability within the operating room.

THE GLOBAL UNITE SYSTEM SURGEON DESIGN TEAM:

Michael Wirth M.D.
(USA)

Joseph Iannotti M.D., PhD
(USA)

Gerald R. Williams, Jr. M.D.
(USA)

Anders Ekelund M.D.
(SWEDEN)

Ludwig Seebauer M.D.
(GERMANY)

Laurent Lafosse M.D.
(FRANCE)

CONTENTS
SURGICAL TECHNIQUE	

KEY INFORMATION	

GLOBAL UNITE System Anatomic Key Surgical Steps	4
Pre-operative Templating	

6

Humeral Head Resection – Intermedullary	

7

Humeral Head Resection – Freehand	

7

Humeral Head Sizing

8

Proximal Humeral Bone Preparation	

8

Trial Implantation	

9

Final Implant Assembly	

11

Final Implant Insertion

12

Conversion to Reverse Total Shoulder

13

Instrument Ordering Information

18

Implant Ordering Information

22

Essential Product Information

24

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    3

KEY SURGICAL STEPS
INTERMEDULLARY RESECTION
Resect the Humeral Head

PRIMARY OR ANATOMIC

Ream the Humeral Canal

Prepare the Proximal Humeral Bone

Resect the Humeral Head

Ream the Humeral Canal and Verify
Osteotomy Angulation

CONVERSION TO REVERSE

FREEHAND RESECTION

Remove the Humeral Head

Remove the Proximal Component

4    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

Establish Epiphysis Version

Insert Humeral Trial Stem

Assemble Final Implant

Size the Proximal Humerus

Prepare the Proximal Humerus

Impact Head and Insert Final Construct

Implant Epiphysis

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    5

PRE-OPERATIVE TEMPLATING

Pre-operative Planning
Pre-operative planning should be carried out using AP
and lateral shoulder radiographs of known magnification
and the available GLOBAL UNITE System implant
template to help the surgeon determine the size and
alignment of the implant. The final decision should
be made intraoperatively.

Figure 1

6    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

HUMERAL HEAD RESECTION

RESECTION METHODS
Option 1: Intermedullary Technique
Starting with the 6mm Bullet Tip Reamer, sequentially
ream the humeral canal until the reamer begins to bite
on cortical bone distally.
Assemble the appropriate right or left Anatomic
Resection Guide to the Quick Clamp and attach
it to the reamer shaft. The posterior cuff guide will
aid in identifying and protecting the posterior rotator
cuff attachment sites.

Figure 2

Adjust the version by placing the Orientation Guide Pin
in the desired version hole on the resection guide and
align with the forearm. Affix the resection guide to
the humerus.
Remove the reamer and quick clamp assembly and
resect the humeral head utilizing an oscillating power
saw (Figure 2).
Option 2: Freehand Technique
Place the Plastic Resection Guides on the anterior
aspect of the arm parallel with the humerus.

Figure 3

Utilize the appropriate angle of the resection guide
(128, 135 or 142) that best matches the patient’s
anatomy and mark the desired angle on the humerus
using electrocautery.

Parallel Alignment: Correct

Resect the humeral head along the marked neck
angle (Figure 3). Once the head has been removed,
sequentially ream the humeral canal.
To verify the resection angle, do not remove the final
reamer. Place the Plastic Resection Guides upside down
on the resection and compare the alignment of the
reamer shaft to the resection guide handles. Parallel
alignment indicates the proper angle (Figure 4). The final
determination of proper angle will be verified during
the implant trialing process.
NOTE: If the reamers are not advanced to the
appropriate position, the brosteotome, humeral trial
or definitive implant may not fully seat in the humerus
and could increase the risk of humeral fracture.

Incorrect

Figure 4

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    7

HUMERAL HEAD SIZING AND PROXIMAL
HUMERAL BONE PREPARATION

Humeral Head Sizing
The humeral head can be provisionally sized using
the GLOBAL UNITE System Anatomic Head Gauge.
The gauge can be utilized to measure both the
diameter and height of the resected humeral
head (Figure 5).
Glenoid Preparation
Place a Cover Plate over the resected surface and
prepare the glenoid.
Note: Please refer to the GLOBAL® APG+ System
surgical technique (0612-13-509) for the detailed
information regarding glenoid preparation.

Figure 5

Proximal Humeral Bone Preparation
Select the Proximal Body Brosteotome that
matches the diameter of the final reamer used
to prepare the humeral canal. If an odd number
reamer was used as the final reamer, select
the brosteotome that is one size smaller.
Place the Proximal Body Brosteotome into the
humeral canal. Correct version is achieved by
aligning an orientation guide pin positioned in the
hole below the cutting fins of the brosteotome with
the plane of the resection (Figure 6a). Alternative,
the humeral preparation version can be determined
by aligning an orientation guide pin placed in the
superior version holes with the axis of the forearm.
Once the desired version is achieved, remove the pin
and reinsert it into the depth stop hole located above
the proximal body of the brosteotome (Figure 6b).
Advance the brosteotome into the humerus using a
mallet. Continue advancing the brosteotome until
the depth stop pin touches the resection.

Figure 6b

Figure 6a

Note: If the brosteotome is difficult to advance,
remove it and clean any bone from the teeth using
the Posterior Cuff Guide. Additional bone removal
with manual instruments (rongeur, burr, ect.)
may be required if hard bone is encountered.

8    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

TRIAL IMPLANTATION

Trial Insertion
Assemble the matching size and angle Proximal
Trial Body to the Distal Trial Stem using the
Female Hex Screw Driver and Distal Stem
Wrench. Attach the assembled trial to the
Implant Holder (Figure 7).
Align the trial with previous preparation steps and
advance into the proximal humerus. Version can
be verified using the orientation guide pin and
the alignment holes on the handle of the implant
holder. The trial is seated when the collar is flush
with the resected humerus (Figure 8).

Figure 7

Note: It is acceptable to modify the neck
resection for a more precise fit by free hand
cutting the resection with a saw or adding
bone augments.

Figure 8

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    9

TRIAL IMPLANTATION

Humeral Head Sizing and Trialing
Select the Humeral Head Trial previously measured.
Place the trial head onto the taper of the proximal
body. The selected trial head should provide coverage
of the resected humerus and should transition
smoothly with the superior cuff insertion
site (Figure 9).
If an eccentric trial head is used, register the position
of the eccentricity by placing a skin marker through
the eccentricity hole and marking on the collar of
the proximal body trial (Figure 10).
Once the trialing process is complete, remove
the trial construct from the humerus using the
implant holder.

Figure 9

Figure 10

11    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

FINAL IMPLANT ASSEMBLY AND IMPLANTATION

Final Implant Assembly and Insertion
When the final implant stem and humeral head
size have been determined, assemble the definitive
implant stem and proximal body together using
the female hex driver and the stem wrench.
Securely tighten the bolt. Place the assembled
implant into the Impaction Stand using the correct
Impaction Slide that matches the size of the
implant. If an eccentric head was selected during
the trialing process, the trial stem must be placed
into the impaction stand and the eccentricity
recorded on the clock face prior to placing the
final implant into the impaction stand (Figure 11).

Figure 11

Place the appropriate sized humeral head onto the
taper of the proximal body. If an eccentric head is
selected, verify eccentricity alignment using the
mark registered on the clock face of the impaction
stand. Impact the humeral head onto the stem
using the Head Impactor (Figure 12).

Figure 12

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    11

FINAL IMPLANT ASSEMBLY AND IMPLANTATION

Final Implant Insertion
The final prosthesis is porous coated and 1.5mm
larger than the trial stem assembly so that in the
majority of cases, a firm press-fit can be obtained
without the use of bone cement.
Align the prosthesis with the prepared bone and
impact the construct with the Head Impactor until
the collar sits flush with the resection (Figure 13).
The humeral head can also be impacted after the
humeral stem has been implanted allowing the
surgeon to retrial the humerus. To perform this
method attach the final stem construct to the
Implant Holder and insert the stem into the humerus
in the intended version. Version can be verified by
placing the orientation guide pin in the proper
version hole of the Implant Holder and aligning
with the axis of the forearm. Implant the definitive
humeral stem using the Implant Holder. Advance
the implant until the collar is flush with the resected
surface. After trialing is complete, position and seat
the selected humeral head implant in the desired
orientation on the humeral implant using the
Head Impactor.

Figure 13

11    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

CONVERSION TO DELTA XTEND™ REVERSE SHOULDER

Removing the Humeral Head
Place the Humeral Head Distractor
in the anterior slot between the head of
the prosthesis and the collar. Tap on the
end of the distractor to disengage the
taper (Figure 14).
Removing the Proximal Component
Use an appropriately sized thin osteotome
from DePuy Synthes’ Shoulder Extraction
Instrument Set to remove the bone on-growth
surrounding the proximal body.

Figure 14

Use the Female Hex Screwdriver to unscrew
the proximal bolt (Figure 15).
Attach the implant inserter to the proximal
body and remove it from the humerus
leaving the well-fixed distal stem.

Figure 15

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    11

CONVERSION TO DELTA XTEND™ REVERSE SHOULDER

Humeral Reaming
Insert the orientation guide pin through
the reaming guide at the desired
epiphysis version.
Place the assembled Epiphyseal Reaming
Guide and orientation guide pin on the
stem by aligning the guide pin to the
forearm while keeping the reaming
guide on the stem spigot (Figure 16).
Tighten the reaming guide screw to
the stem using the 3.5mm Male Hex
Screwdriver. Place the Sizing Guides
onto the reaming guide in order to
determine the correct reverse epiphysis
size. The correct size will be contained
within the cortical wall (Figure 17).

Figure 16

Note: The GLOBAL UNITE System
allows eccentric reaming and preparation
of the proximal humerus to better match
anatomy. Assure that the proper reamer
guide is utilized (Right, Center or Left) to
achieve the desired outcome.

Figure 17

11    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

CONVERSION TO DELTA XTEND™ REVERSE SHOULDER

Select the color coded Epiphyseal Reamer
(red or green) determined during the sizing
exercise and prepare the proximal humerus by
using power (Figure 18). Once the reaming
process has been completed the reamer guide
can be removed utilizing the 3.5mm hex
screwdriver (yellow handle).
Utilize an osteotome or ronguer to remove
any bone that may remain around the
proximal portion of the distal stem that
can prevent the proximal component
from completely engaging with the
stem (Figure 19).

Figure 18

Figure 19

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    11

CONVERSION TO DELTA XTEND™ REVERSE SHOULDER

Attaching the Trial Epiphysis Component
to the Distal Stem
Attach the DELTA XTEND™ Reverse Shoulder System
trial epiphysis to the Reverse Epiphysis Holder by
squeezing the distal portion and placing it within
the epiphysis. Align the pins on the outside of the
epiphyseal holder with the notches on the implant
and release the holder, this will lock the two
components together (Figure 20).
Place the Orientation Guide Pin through the
retroversion hole that was originally determined
during the reaming process (Figure 21). Align the
trial epiphysis to the stem and align the pin to
the forearm.

Figure 20

Figure 21

11    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

CONVERSION TO DELTA XTEND™ REVERSE SHOULDER

Once the component is in proper orientation,
place the 3.5mm Male Hex Screwdriver
(yellow handle) through the inner portion of the
reverse epiphysis holder and securely tighten the
bolt. Remove the reverse epiphyseal holder when
this step has been completed (Figure 22). Remove
any bone on the superior aspect of the trial
epiphysis that could cause impingement with
the final implant. This can be done with an
oscillating saw while using the trial epiphysis
as a guide.
Once the proximal component has been
secured to the stem, complete all other
steps of the procedure consistent with the
DELTA XTEND Reverse Shoulder System
through final implantation.
Please refer to DELTA XTEND System
Surgical Technique (0612-53-505) for the
remaining portion of procedure.

Figure 22

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    11

INSTRUMENT ORDERING INFORMATION
COMMON CASE

Top Tray – Humeral Preparation	
2128-11-006	

Bullet Tip Reamer 6mm

2128-11-007	

Bullet Tip Reamer 7mm

2128-11-008	

Bullet Tip Reamer 8mm

2128-11-009	

Bullet Tip Reamer 9mm

2128-11-010	

Bullet Tip Reamer 10mm

2128-11-011	

Bullet Tip Reamer 11mm

2128-11-012	

Bullet Tip Reamer 12mm

2128-11-013	

Bullet Tip Reamer 13mm

2128-11-014	

Bullet Tip Reamer 14mm

2128-11-015	

Bullet Tip Reamer 15mm

2128-11-016	

Bullet Tip Reamer 16mm

2128-61-070	

Ratchet T-Handle

2307-84-001	

Stem Wrench 10 – 12mm

2307-84-002	

Stem Wrench 14 – 16mm

2307-84-003	

Stem Wrench 6 – 8mm

2100-06-100	

Humeral Stem 6mm Trial

2100-08-100	

Humeral Stem 8mm Trial

2100-10-100	

Humeral Stem 10mm Trial

2100-12-100	

Humeral Stem 12mm Trial

2100-14-100	

Humeral Stem 14mm Trial

2100-16-100	

Humeral Stem 16mm Trial

11    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

INSTRUMENT ORDERING INFORMATION
COMMON CASE

Bottom Tray – Trial Heads	
2130-20-000	

3.2mm Osteotomy Guide Pin – Long

2100-22-401	

Common Humeral Head 40 X 15 Eccentric Trial

2100-70-155	

4.0mm Female Hex Screwdriver

2100-22-402	

Common Humeral Head 40 X 18 Eccentric Trial

2100-70-150	

3.5mm Hex Screwdriver

2100-22-441	

Common Humeral Head 44 X 15 Eccentric Trial

2001-65-000	

Humeral Head Impactor

2100-22-442	

Common Humeral Head 44 X 18 Eccentric Trial

2100-01-022	

Impaction Stand

2100-22-443	

Common Humeral Head 44 X 21 Eccentric Trial

2100-11-400	

Common Humeral Head 40 X 12 Trial

2100-22-481	

Common Humeral Head 48 X 15 Eccentric Trial

2100-11-401	

Common Humeral Head 40 X 15 Trial

2100-22-482	

Common Humeral Head 48 X 18 Eccentric Trial

2100-11-402	

Common Humeral Head 40 X 18 Trial

2100-22-483	

Common Humeral Head 48 X 21 Eccentric Trial

2100-11-440	

Common Humeral Head 44 X 12 Trial

2100-22-521	

Common Humeral Head 52 X 15 Eccentric Trial

2100-11-441	

Common Humeral Head 44 X 15 Trial

2100-22-522	

Common Humeral Head 52 X 18 Eccentric Trial

2100-11-442	

Common Humeral Head 44 X 18 Trial

2100-22-523	

Common Humeral Head 52 X 21 Eccentric Trial

2100-11-443	

Common Humeral Head 44 X 21 Trial

2100-22-562	

Common Humeral Head 56 X 18 Eccentric Trial

2100-11-481	

Common Humeral Head 48 X 15 Trial

2100-22-563	

Common Humeral Head 56 X 21 Eccentric Trial

2100-11-482	

Common Humeral Head 48 X 18 Trial

2100-11-483	

Common Humeral Head 48 X 21 Trial

2100-11-521	

Common Humeral Head 52 X 15 Trial

2100-11-522	

Common Humeral Head 52 X 18 Trial

2100-11-523	

Common Humeral Head 52 X 21 Trial

2100-11-562	

Common Humeral Head 56 X 18 Trial

2100-11-563	

Common Humeral Head 56 X 21 Trial

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    11

INSTRUMENT ORDERING INFORMATION
ANATOMIC CASE

Top Tray – Anatomic	

Bottom Tray – Anatomic	

2128-01-021	

Humeral Head Distractor

2100-05-006	

Proximal Humeral Brosteotome 6

2236-26-000	

Modified Crego Retractor

2100-05-008	

Proximal Humeral Brosteotome 8

2100-70-005	

Impaction Slide - Anatomic Stems 6 - 12

2100-05-010	

Proximal Humeral Brosteotome 10

2100-70-006	

Impaction Slide - Anatomic Stems 14 - 16

2100-05-012	

Proximal Humeral Brosteotome 12

2100-01-020	

Anatomic Head Guage

2100-05-014	

Proximal Humeral Brosteotome 14

2236-31-000	

Plastic Darrach

2100-05-016	

Proximal Humeral Brosteotome 16

2100-61-071	

Celcon Cutting Guide 128 & 142 Degree

2100-20-016	

Trial Body 6/8 – 128 Degree

2128-61-071	

Celcon Cutting Guide 135 Degree

2100-30-016	

Trial Body 10 – 128 Degree

2490-95-000	

3.2mm Fixation Pins Qty 3

2100-40-016	

Trial Body 12 – 128 Degree

2128-62-110	

Anatomic Resection Guide - Right

2100-50-016	

Trial Body 14 – 128 Degree

2128-62-130	

Posterior Cuff Guide - Right

2100-60-016	

Trial Body 16 – 128 Degree

2128-62-150	

Cutting Guide Quick Clamp

2100-20-015	

Trial Body 6/8 – 135 Degree

2128-62-120	

Posterior Cuff Guide - Left

2100-30-015	

Trial Body 10 – 135 Degree

2128-62-100	

Anatomic Resection Guide - Left

2100-40-015	

Trial Body 12 – 135 Degree

2128-65-200	

Small Cover Plate

2100-50-015	

Trial Body 14 – 135 Degree

2128-65-250	

Large Cover Plate

2100-60-015	

Trial Body 16 – 135 Degree

2100-20-017	

Trial Body 6/8 – 142 Degree

2100-30-017	

Trial Body 10 – 142 Degree

2100-40-017	

Trial Body 12 – 142 Degree

2100-50-017	

Trial Body 14 – 142 Degree

2100-60-017	

Trial Body 16 – 142 Degree

2100-01-135	

Anatomic Implant Holder

22    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

INSTRUMENT ORDERING INFORMATION
REVISION CASE
Top Tray
2100-70-500	

Epiphyseal Sizer 1

2100-70-510	

Epiphyseal Sizer 2

2100-70-600	

Epiphyseal Reamer 1

2100-70-610	

Epiphyseal Reamer 2

2100-70-410	

Epiphyseal Reamer Guide

2100-70-415 	 Epiphyseal Reamer Guide Left
2100-70-420 	 Epiphyseal Reamer Guide Right
2100-70-700	

Reverse Epiphyseal Holder

2130-01-120	

Humeral Head Distractor

2307-99-002	

Extraction T-Handle

2130-20-000	

3.2mm Osteotomy Guide Pin – Long

2100-70-155	

4.0mm Female Hex Screwdriver

2100-70-150 	

3.5 Male Hex Screwdriver

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    22

IMPLANT ORDERING INFORMATION
Standard Humeral Stem Components

Humeral Head Components

1100-06-100	

Standard Humeral Stem 6mm x 83mm

1100-40-500	

Humeral Head 40 x 15

1100-08-100	

Standard Humeral Stem 8mm x 107mm

1100-40-510	

Humeral Head 40 x 18

1100-10-100	

Standard Humeral Stem 10mm x 113mm

1100-44-500	

Humeral Head 44 x 15

1100-12-100	

Standard Humeral Stem 12mm x 121mm

1100-44-510	

Humeral Head 44 x 18

1100-14-100	

Standard Humeral Stem 14mm x 130mm

1100-44-520	

Humeral Head 44 x 21

1100-16-100	

Standard Humeral Stem 16mm x 138mm

1100-48-500	

Humeral Head 48 x 15

1100-48-510	

Humeral Head 48 x 18

1100-48-520	

Humeral Head 48 x 21

Humeral Long Stem Components
1100-06-600	

Long Humeral Stem 6mm x 143mm

1100-52-500	

Humeral Head 52 x 15

1100-08-600	

Long Humeral Stem 8mm x 177mm

1100-52-510	

Humeral Head 52 x 18

1100-10-600	

Long Humeral Stem 10mm x 183mm

1100-52-520	

Humeral Head 52 x 21

1100-12-600	

Long Humeral Stem 12mm x 191mm

1100-56-510	

Humeral Head 56 x 18

1100-56-520	

Humeral Head 56 x 21

1100-40-600	

Humeral Head 40 x 15 Eccentric

1100-40-610	

Humeral Head 40 x 18 Eccentric

Anatomic Proximal Bodies
110020000	

Anatomic Proximal Body 135 SZ 6/8

1100-44-600	

Humeral Head 44 x 15 Eccentric

110030000	

Anatomic Proximal Body 135 SZ 10

1100-44-610	

Humeral Head 44 x 18 Eccentric

110040000	

Anatomic Proximal Body 135 SZ 12

1100-44-620	

Humeral Head 44 x 21 Eccentric

110050000	

Anatomic Proximal Body 135 SZ 14

1100-48-600	

Humeral Head 48 x 15 Eccentric

110060000	

Anatomic Proximal Body 135 SZ 16

1100-48-610	

Humeral Head 48 x 18 Eccentric

110020010	

Anatomic Proximal Body 128 SZ 6/8

1100-48-620	

Humeral Head 48 x 21 Eccentric

110030010	

Anatomic Proximal Body 128 SZ 10

1100-52-600	

Humeral Head 52 x 15 Eccentric

110040010	

Anatomic Proximal Body 128 SZ 12

1100-52-610	

Humeral Head 52 x 18 Eccentric

110050010	

Anatomic Proximal Body 128 SZ 14

1100-52-620	

Humeral Head 52 x 21 Eccentric

110060010	

Anatomic Proximal Body 128 SZ 16

1100-56-610	

Humeral Head 56 x 18 Eccentric

110020020	

Anatomic Proximal Body 142 SZ 6/8

1100-56-620	

Humeral Head 56 x 21 Eccentric

110030020	

Anatomic Proximal Body 142 SZ 10

110040020	

Anatomic Proximal Body 142 SZ 12

110050020	

Anatomic Proximal Body 142 SZ 14

110060020	

Anatomic Proximal Body 142 SZ 16

Anchor Peg Glenoid Implants
Featuring PREMERON® X-Linked Polyethylene
1136-40-026	

Cross-linked Anchor Peg Glenoid 40mm

1136-41-026	

Cross-linked Anchor Peg Glenoid 44mm

1136-42-026	

Cross-linked Anchor Peg Glenoid 48mm

1136-43-026	

Cross-linked Anchor Peg Glenoid 52mm

1136-44-026	

Cross-linked Anchor Peg Glenoid 56mm

22    DePuy Synthes Joint Reconstruction  GLOBAL® UNITE ® Anatomic Surgical Technique

IMPLANT ORDERING INFORMATION
Metaglene Components

Metaglene Screw Components

1307-60-000	Metaglene

1307-70-018	

Non Locking Metaglene Screw 4.5mm x 18mm

1407-60-020 	 +10mm Long Peg Metaglene

1307-70-024	

Non Locking Metaglene Screw 4.5mm x 24mm

1407-60-025 	 +15mm Long Peg Metaglene

1307-70-030	

Non Locking Metaglene Screw 4.5mm x 30mm

1307-70-036	

Non Locking Metaglene Screw 4.5mm x 36mm

1307-70-042	

Non Locking Metaglene Screw 4.5mm x 42mm

1307-90-024	

Locking Metaglene Screw 4.5mm x 24mm

1307-90-030	

Locking Metaglene Screw 4.5mm x 30mm

1307-90-036	

Locking Metaglene Screw 4.5mm x 36mm

1307-90-042	

Locking Metaglene Screw 4.5mm x 42mm

1307-90-048	

Locking Metaglene Screw 4.5mm x 48mm

Glenosphere Components
1307-60-138	

Glenosphere 38mm

1307-60-142	

Glenosphere 42mm

1307-60-038	

Glenosphere 38mm Eccentric

1307-60-042	

Glenosphere 42mm Eccentric

Modular Epiphyseal Components
1307-20-101 	 Modular Centered Epiphysis Size 1 HA
1307-20-102 	 Modular Eccentric Epiphysis Size 1 Left HA
1307-20-103 	 Modular Eccentric Epiphysis Size 1 Right HA
1307-20-201 	 Modular Centered Epiphysis Size 2 HA
1307-20-202 	 Modular Eccentric Epiphysis Size 2 Left HA
1307-20-203 	 Modular Eccentric Epiphysis Size 2 Right HA

Polyethylene Cup and Humeral Spacer
1307-38-203	

Humeral Polyethylene Cup 38mm +3mm

1307-38-206	

Humeral Polyethylene Cup 38mm +6mm

1307-38-209	

Humeral Polyethylene Cup 38mm +9mm

1307-42-203	

Humeral Polyethylene Cup 42mm +3mm

1307-42-206	

Humeral Polyethylene Cup 42mm +6mm

1307-42-209	

Humeral Polyethylene Cup 42mm +9mm

1307-38-106	

Humeral Polyethylene Cup 38mm +6mm Retentive

1307-42-106	

Humeral Polyethylene Cup 42mm +6mm Retentive

1307-38-703	

High Mobility PREMIERON® X-Linked Humeral Cup 38mm +3mm

1307-38-706	

High Mobility PREMIERON® X-Linked Humeral Cup 38mm +6mm

1307-38-709	

High Mobility PREMIERON® X-Linked Humeral Cup 38mm +9mm

1307-42-703	

High Mobility PREMIERON® X-Linked Humeral Cup 42mm +3mm

1307-42-706	

High Mobility PREMIERON® X-Linked Humeral Cup 42mm +6mm

1307-42-709	

High Mobility PREMIERON® X-Linked Humeral Cup 42mm +9mm

1307-30-009	

Humeral Spacer +9mm

Surgical Technique  GLOBAL® UNITE ® Anatomic DePuy Synthes Joint Reconstruction    22

IMPORTANT

WARNINGS AND PRECAUTIONS

This Essential Product Information sheet does not include all of the information necessary
for selection and use of the device. Please see full labeling for all necessary information.

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

INDICATIONS

•	 DePuy Synthes’ 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.

Total shoulder or hemi-shoulder replacement is indicated for:
1.	 A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or
rheumatoid arthritis;
2.	 Fracture-dislocations of the proximal humerus where the articular surface is severely
comminuted, separated from its blood supply or where the surgeon’s experience
indicates that alternative methods of treatment are unsatisfactory;
3.	 Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are
not acceptable (e.g., revision of a failed primary component).
Hemi-shoulder replacement is also indicated for:
1.	 Ununited humeral head fractures;
2.	 Avascular necrosis of the humeral head;
3.	 Deformity and/or limited motion.
When used in a total shoulder replacement, the GLOBAL UNITE System Implants are to
be used with DePuy Synthes Joint Reconstruction’s glenoids. The glenoids are for cemented
use only.
When well-fixed, the GLOBAL UNITE System Humeral Stems, in conjunction with existing
Delta Xtend Epiphyseal Components, are also indicated for conversion to a reverse, in
treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously
failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be
anatomically and structurally suited to receive the selected implant(s), and a functional
deltoid muscle is necessary. The DELTA XTEND System Metaglene is HA-coated and is
intended for uncemented use with the addition of screws for fixation. The DELTA XTEND
System Epiphyseal Components are HA-coated and are intended for uncemented use.

CONTRAINDICATIONS
The following conditions are contraindications for total shoulder and hemi-shoulder
arthroplasty:
1.	 Active local or systemic infection;
2.	 Poor bone quality, such as osteoporosis, where there could be considerable migration
of the prosthesis and/or a chance of fracture of the humerus or glenoid;
3.	 Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the
components (Note: This contraindication does not apply when converting to a reverse);
4.	 Absent, irreparable or nonfunctional rotator cuff or other essential muscles
	 (Note: This contraindication does not apply when converting to a reverse.)
Please review the full labeling for DELTA XTEND System Metaglene when converting
to a reverse.

•	 Always use a trial prosthesis for trial purposes. Trials should never be used as an implant.
•	 Do not alter or modify implants in any way.
•	 GLOBAL UNITE System Standard and Eccentric Humeral Heads are intended to be used
with either GLOBAL UNITE or GLOBAL® AP® System Humeral Components. DO NOT USE
the 40x12 mm or 44x12 mm GLOBAL UNITE Standard Humeral Heads with the GLOBAL
AP humeral components, as their compatibility has not been established.
•	 The use of a glenoid prosthesis in patients with cuff tear arthropathy could increase the
risk of glenoid component loosening due to non-anatomic loading conditions.
•	 When used with multiple components of a total shoulder 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 Synthes Joint Reconstruction recommends that a professional familiar with the
specific MRI apparatus to be used assess the patient prior to any MRI examination
or therapy.
The following conditions, singularly or concurrently, tend to impose severe loading on the
affected extremity, thereby placing the patient at higher risk for failure of the shoulder
arthroplasty:
1.	 Obesity or excessive patient weight.
2. 	Manual labor.
3. 	Active sports participation.
4. 	High levels of patient activity.
5. 	Likelihood of falls.
6. 	Alcohol or drug addictions.
7.	 Other disabilities, as applicable.

ADVERSE EVENTS AND COMPLICATIONS
The following events are generally the most frequently encountered adverse events and
complications in total and hemi shoulder arthroplasty:
1. Change in position of the prosthesis, often related to factors listed in the Warnings
and Precautions
2. Early or late infections
3. Early or late loosening of the prosthetic component(s), often related to factors listed
in the Warnings and Precautions

Limited Warranty and Disclaimer: DePuy Synthes Joint Reconstruction products are sold with a limited warranty to the original purchaser against defects
in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.
WARNING: In the USA, this product has labeling limitations. See package insert for complete information.
CAUTION: USA Law restricts these devices to sale by or on the order of a physician.
Not all products are currently available in all markets. The third party trademarks used herein are trademarks of their respective owners.

DePuy Synthes Joint Reconstruction
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.
*DePuy Synthes Joint Reconstruction is a division of DePuy Orthopaedics, Inc.
0612-41-515 1.5M 0414



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