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Copeland™/Copeland™ EAS™

Humeral Resurfacing Head

Surgical Technique

Knees • Hips • Extremities • Cement and Accessories • PMI • Technology

Table of Contents

Patient Positioning and Approaches........................................................................................... 1
Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

Surgical Technique
Copeland™ Humeral Resurfacing Head................................................................................ 5
Copeland™ EAS™ Humeral Resurfacing Head...................................................................... 9

Closure and Postoperative Care................................................................................................ 13
Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

Ordering Information................................................................................................................... 15
Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

The general considerations, surgical technique and postoperative management
instructions herein are those described by Stephen A. Copeland, F.R.C.S., Director
Reading Shoulder Unit, Berkshire UK, Chairman International Board Shoulder and
Elbow Surgeons (IBSES). Biomet, as the manufacturer of this device, does not
practice medicine and does not recommend this device or technique. Each surgeon
is responsible for determining the appropriate device and technique to utilize on
each individual patient.
The EAS™ Humeral Head surgical technique and postoperative management
instructions are those utilized by David Bailie, M.D., The Orthopedic Clinic
Association, Scottsdale, AZ. Biomet, as the manufacturer of this device, does not
practice medicine and does not recommend this device or technique. Each surgeon
is responsible for determining the appropriate device and technique to utilize on
each individual patient. The Copeland™ Surface Replacement Arthroplasty (CSRA)
of the shoulder was developed by Stephen A. Copeland, F.R.C.S., Director Reading
Shoulder Unit, Berkshire UK, Chairman International Board Shoulder and Elbow
Surgeons (IBSES).

Patient Positioning and Approaches

Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

1

Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

Patient Positioning and Approaches

Figure 2a

Figure 1 Figure 2

Surgical Position Deltopectoral Approach

Place the patient in a semi-sitting or beach chair position. Surgical Incision

General Considerations Make a 15cm incision from the clavicle down across the
tip of the coracoid and continue in a straight line to the
The prosthesis may be inserted using either technique anterior border of the insertion of the deltoid (Figure 1).
listed below:
Approach
A. The standard anterior deltopectoral approach
B. The antero-superior “Mackenzie” approach Laterally mobilize the cephalic vein in the deltopectoral
groove and retract laterally with the deltoid. Abduct the
If the rotator cuff is intact or a repairable rotator cuff arm 40 to 60 degrees and incise the clavipectoral fascia.
defect is present, make an anterior acromioplasty with Clear the subacromial space and place a broad elevator
partial resection of the coracoacromial ligament. If there beneath the acromion as a retractor. At this stage, divide
is complete loss of rotator cuff, do not disturb the the proximal 2cm of the insertion of pectoralis major to
coracoacromial arch. If preoperative X-rays indicate an obtain improved exposure (Figure 2). Flex the shoulder
arthritic change at the acromioclavicular joint and and externally rotate to facilitate coagulation of the
symptoms suggest this is a site of pain, perform an anterior circumflex humeral vessels. Insert stay sutures
excision arthroplasty at this stage to improve exposure. into the subscapularis muscle to control retraction
(Figure 2a). Divide the tendon 2cm medial to the bicipital
groove. If it appears tight, divide the subscapularis in an

2

Figure 3 Figure 4

oblique or “Z” manner to allow repair with lengthening Antero-Superior “Mackenzie”
of the tendon. Release the joint capsule anteriorly and Approach
inferiorly, while protecting the axillary nerve with a blunt
elevator where it passes through the quadrilateral space. Surgical Incision
Dislocate the glenohumeral joint anteriorly by external
rotation and extension, allowing full exposure of the Make a skin incision that extends distally in a straight
humeral head and neck. line from just posterior to the acromioclavicular joint for a
distance of 9cm (Figure 3).

Approach

Split the anterior deltoid fibers for a distance of not more
than 6cm and place a loose No. 1 stay suture in the
distal end of the split to prevent further extension and
possible injury to axillary nerve. Using an osteo-periosteal
flap, lift the acromial attachment of the deltoid to expose
the anterior acromion and preserve the superior
acromioclavicular ligament (Figure 4). Perform an anterior
acromioplasty according to the Neer technique. If further
exposure is necessary, excise the lateral end of 1cm
of clavicle.

3

Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

Patient Positioning and Approaches

Route of Route of
antero-superior deltopectoral
exposure exposure

Pectoralis major

Figure 5 Deltoid
Approach Comparisons

Both Approaches

Identify the rotator interval and longitudinally incise along
the line of the long head of the biceps to identify the exact
insertion of the subscapularis. Using stay sutures, hold
the subscapularis and disinsert (Figure 5). Dislocate the
shoulder anteriorly. If intact, dislocate the long head of the
biceps posteriorly over the humeral head.

4

Surgical Technique

Copeland™ Humeral Resurfacing Head

5

Copeland™ Humeral Resurfacing Head

Surgical Technique

Figure 8a

Figure 6 Figure 7 Figure 8

Humeral Head Preparation Note the degree of natural retroversion between the
angle of the guide wire and the forearm when flexed at 90
Define the anatomic neck of the humerus by removing degrees. Do not attempt a fixed degree of version, as the
any osteophytes, which is essential for determining the goal is reproduction of the anatomic version (ranging from
anatomical neck but not for shaping the humeral head. 5 to 55 degrees of retroversion). Remove the humeral
This also allows for more accurate positioning of the drill guide and check the position of the Steinmann pin to
humeral drill guide. ensure that it is both anatomic and centered in the
humeral head (Figures 8 and 8a).
Place a cannulated humeral drill guide on top of the
humeral head. Orient the bottom edge of the guide
parallel to the anatomical neck (Figure 6). After assessing
for anterior/posterior placement, center the guide on
the humeral head (Figure 7). This position automatically
builds in the anatomical degrees of retroversion and
inclination. Pass a 7⁄64" Steinmann pin guide wire
down through the humeral head guide into the
humeral head to the lateral cortex to provide stability.

6

Figure 11a

Figure 9 Figure 10 Figure 11

Using a cannulated power drill with a ¼" Jacobs chuck or Pass the cannulated spade bit over the guide wire and
Hudson adapter, shape the humeral head by passing the make the central peg hole down to the “stop” of the bit
cannulated humeral surface cutter over the Steinmann (Figures 11 and 11a). Remove the bit and guide wire.
pin. Holding the sleeve of the surface reamer tightly, Morselized bone generated by making this pilot hole may
gently press down onto the humeral head while the be saved for later grafting.
reamer is rotating (Figure 9). Bone will begin to appear
through the holes in the surface cutter. The humeral To continue to the Copeland™ EAS™ Head Surgical
surface cutter facilitates complete bony apposition to the Technique refer to page 10.
undersurface of the prosthesis and also delineates the
edge of where the prosthesis will meet the bone. The
edge of this cut will appear beneath the native surface of
the bone (Figure 10).

Note: It may be necessary to remove bone from the
periphery of the head. If possible, the hard subchondral
plate should be left intact, as this provides good
prosthetic support.

7

Copeland™ Humeral Resurfacing Head

Surgical Technique

Figure 12a

Figure 12 Figure 13

Humeral Head Insertion Remove the trial humeral component and examine the
humeral head. If desired place bone slurry within the peg
The thickness of the prosthesis should build up the hole. Prior to impaction of both the glenoid and humeral
recently cut surface of the humeral head back to the components any hard sclerotic areas are drilled through
anatomical surface of the bone. Place the trial humeral to cancellous bone to make these surfaces more reactive
prosthesis onto the prepared bone and perform a trial with the bone graft. Press-fit the component by placing
reduction (Figure 12). At this time, evaluate stability and the resurfacing head implant onto the prepared humeral
range of motion. Also, check the prosthesis for stability head and seating the component about two-thirds of the
in flexion/extension. If a sizing adjustment is needed, way with finger pressure. (When cementing, fill the peg
use the surface cutter guide for additional reaming hole with the desired amount of cement before placing
(Figure 12a). the component.) Impact the humeral prosthesis until it is
flush against the bone (Figure 13).

8

Surgical Technique

Copeland™ EAS™ Humeral Resurfacing Head

9

Copeland™ EAS™ Humeral Resurfacing Head

Surgical Technique

Bicipital Groove

Figure 14a

Figure 14 Figure 15 Figure 16

Place the appropriate EAS™ cutting guide (based on portion of the cutting guide and mark the humerus with
STD resurfacing technique) onto the prepared surface an electrocautery at the appropriate color-coded marking
(Figure 14). Make sure the central guide slot is over the on the depth gauge. Next, make the anterior and posterior
superior portion of the greater tuberosity that is to be cuts* with the saw angled proximally toward the lateral
removed. The left (L) or right (R) markings should line cut to insure the proper amount of bone removal
up with the bicipital groove (Figure 14a) depending on (Figure 16).
operative side. Note: If doing a left shoulder, the left
line would be targeted at the bicipital groove. To hold
the EAS™ cutting guide in the desired position, insert two
quick release guide pins—one on the surface and another
in the inferior rim. Make the superior cut* (Figure 15). An
optional depth guide is available to maximize bone
conservation. Lay the depth gauge on the superior

*An 85x13x.89mm Stablecut® sawblade, part number 506090, is recommended.

10

Figure 17 Figure 18 Figure 19

Humeral Head Insertion Remove the trial humeral component and examine the
humeral head. If desired place bone slurry within the peg
The thickness of the prosthesis should build up the hole. Press-fit the component by placing the resurfacing
recently cut surface of the humeral head back to the head prosthesis onto the prepared humeral head and
normal anatomic surface of the bone (Figure 17). Place seating the component about two-thirds of the way with
the trial humeral prosthesis onto the prepared bone and finger pressure. (When cementing, partially fill the peg
perform a trial reduction (Figure 18). At this time, evaluate hole with cement before placing the component.) Impact
stability and range of motion. Also, check the prosthesis the humeral prosthesis until it is flush against the bone
for stability in flexion/extension. Finally, ensure the (Figure 19).
subacromial articulation is accurate so the lateral wing
of the implant rides smoothly beneath the acromion with
abduction. The goal is to maximize contact of the implant
with the glenoid and acromion simultaneously.

11

Notes:

12

Closure and Postoperative Care

Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

13

Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

Closure and Postoperative Care

Closure Antero-Superior “Mackenzie”
Approach
While applying tension to the subscapularis stay sutures,
assess the position of reattachment to the subscapularis. Repair the subscapularis using No. 1 suture material
Due to the resultant lateralization of the center of rotation, (absorbable PDSII® or non-absorbable) without plicating
attempt to gain relative length in the subscapularis by the subscapularis or through bone sutures. Close the
performing either a Z-plasty on the subscapularis when rotator cuff interval. If rotator cuff deficiency is present,
entering the joint or by medializing the insertion of the perform routine rotator cuff repair at this stage. Make every
subscapularis to the free edge of the prosthesis. attempt to close the rotator cuff completely. Reattach the
deltoid to the acromion with No. 1 absorbable sutures
Deltopectoral Approach (PDSII®) through bone. Approximate the deltoid split
with 2/0 absorbable sutures. Oppose subcutaneous fat
Repair the subscapularis using No. 1 suture material with absorbable sutures and undertake appropriate skin
(absorbable PDSII® or non-absorbable) without plicating closure with intradermal continuous absorbable sutures
the subscapularis or through bone sutures. Close the (3/0 Monocryl®).
rotator interval. If rotator cuff deficiency is present,
perform routine rotator cuff repair at this stage. Make Postoperative
every attempt to close the rotator cuff completely. Close
the deltopectoral interval using two or three interrupted Place the patient in a sling with bodybelt and use brachial
absorbable sutures. Oppose subcutaneous fat with block analgesia. Passive mobilizing is recommended for
absorbable sutures and undertake appropriate skin the first 48 hours, with passive assistance for five days
closure with intradermal continuous absorbable sutures thereafter. Reintroduce active movement as pain allows
(3/0 Monocryl®). and abandon the sling at three weeks. Begin a stretching
and strengthening program as standard for all shoulder
14 replacements.

Ordering Information

Copeland™/Copeland™ EAS™ Humeral Resurfacing Head

15

Copeland™/Copeland™ EAS™ Head Ordering Information

Implants Implant Part Description Size
Number 1
Implant Image Copeland™ Macrobond® Coated 2
11-114621 Humeral Resurfacing Head 3
11-114622 4
11-114623 Copeland™ Macrobond® Coated 5
11-114624 Humeral Resurfacing Head 6
11-114625 7
11-114626 Copeland™ Macrobond® Coated 8
11-114627 Humeral Resurfacing Head 1
11-114628 2
11-114641 Copeland™ Macrobond® Coated 3
11-114642 Humeral Resurfacing Head 4
11-114643 5
11-114644 Copeland™ Macrobond® Coated 6
11-114645 Humeral Resurfacing Head 7
11-114646 8
11-114647 Copeland™ Macrobond® Coated
11-114648 Humeral Resurfacing Head

Copeland™ Macrobond® Coated
Humeral Resurfacing Head

Copeland™ Macrobond® Coated
Humeral Resurfacing Head

Copeland™ HA Coated Humeral
Resurfacing Head

Copeland™ HA Coated Humeral
Resurfacing Head

Copeland™ HA Coated Humeral
Resurfacing Head

Copeland™ HA Coated Humeral
Resurfacing Head

Copeland™ HA Coated Humeral
Resurfacing Head

Copeland™ HA Coated Humeral
Resurfacing Head

Copeland™ HA Coated Humeral
Resurfacing Head

Copeland™ HA Coated Humeral
Resurfacing Head

16

Implant Image Implant Part Description Size
Number 1
Instruments Copeland™ EAS™ Macrobond®/HA 2
11-114661 Coated Humeral Resurfacing Head 3
Product 4
11-114662 Copeland™ EAS™ Macrobond®/HA 5
Coated Humeral Resurfacing Head 6
11-114663 7
Copeland™ EAS™ Macrobond®/HA 8
11-114664 Coated Humeral Resurfacing Head

11-114665 Copeland™ EAS™ Macrobond®/HA
Coated Humeral Resurfacing Head
11-114666
Copeland™ EAS™ Macrobond®/HA
11-114667 Coated Humeral Resurfacing Head

11-114668 Copeland™ EAS™ Macrobond®/HA
Coated Humeral Resurfacing Head

Copeland™ EAS™ Macrobond®/HA
Coated Humeral Resurfacing Head

Copeland™ EAS™ Macrobond®/HA
Coated Humeral Resurfacing Head

Part Number Description Size
7⁄64" x 9"
27-361478 Steinmann Pin/Trocar Point
1
402600 Copeland™ Humeral Drill Guide 2
402601 Copeland™ Humeral Drill Guide 3
402602 Copeland™ Humeral Drill Guide 4
402604 Copeland™ Humeral Drill Guide 5
402606 Copeland™ Humeral Drill Guide 6
402607 Copeland™ Humeral Drill Guide 7
402609 Copeland™ Humeral Drill Guide 8
402608 Copeland™ Humeral Drill Guide 1
2
402620 Copeland™ Surface Cutter 3
402621 Copeland™ Surface Cutter 4
402622 Copeland™ Surface Cutter 5
402624 Copeland™ Surface Cutter 6
402626 Copeland™ Surface Cutter 7
402627 Copeland™ Surface Cutter 8
402629 Copeland™ Surface Cutter
402628 Copeland™ Surface Cutter –
–
402610 Spade Cutter
402612 Spade Cutter 17

Copeland™/Copeland™ EAS™ Head Ordering Information

Product Part Number Description Size

402642 Copeland™ Surface Cutter Guide 1,2
402644 Copeland™ Surface Cutter Guide 3, 4, 5, 6, 7, 8

402630 Copeland™ Humeral Provisional 1
402631 Copeland™ Humeral Provisional 2
402632 Copeland™ Humeral Provisional 3
402634 Copeland™ Humeral Provisional 4
402636 Copeland™ Humeral Provisional 5
402637 Copeland™ Humeral Provisional 6
402639 Copeland™ Humeral Provisional 7
402638 Copeland™ Humeral Provisional 8

406514 Bio-Modular® Humeral Head Impactor –

402640 Copeland™ Humeral Extractor –

406699 Fukada Retractor –
994500850 Bent Ring Retractor –

18

Product Part Number Description Size
1
*Includes outer, upper, and inner trays. 402651 Copeland™ EAS™ Cutting Guide 2
402652 Copeland™ EAS™ Cutting Guide 3
402653 Copeland™ EAS™ Cutting Guide 4
402654 Copeland™ EAS™ Cutting Guide 5
402655 Copeland™ EAS™ Cutting Guide 6
402656 Copeland™ EAS™ Cutting Guide 7
402657 Copeland™ EAS™ Cutting Guide 8
402658 Copeland™ EAS™ Cutting Guide 1
2
402661 Copeland™ EAS™ Provisional 3
402662 Copeland™ EAS™ Provisional 4
402663 Copeland™ EAS™ Provisional 5
402664 Copeland™ EAS™ Provisional 6
402665 Copeland™ EAS™ Provisional 7
402666 Copeland™ EAS™ Provisional 8
402667 Copeland™ EAS™ Provisional
402668 Copeland™ EAS™ Provisional –

402672 Quick Release Trocar Pin –

406669 Steinmann Pin Threaded Tip (optional)

32-420160 Pin Inserter/Extractor –

32-486259 Quick Release Attachment –

402674 Depth Gauge –

506090 Stablecut® Sawblade 85 x 13 x .89mm

595210 Copeland™ Instrument Case Outer –
595212 Copeland™ Upper Instrument Tray –
595213 Copeland™ Lower Instrument Tray –
595214 Copeland™ EAS™ Instrument Case* –

19

Biomet Orthopedics, Inc. 01-50-0973 Do not reuse implants. While an implant may appear undamaged, previous stress may have
P.O. Box 587 Date: 01/02 created imperfections that would reduce the service life of the implant. Do not treat patients with
56 East Bell Drive implants that have been, even momentarily, placed in a different patient.
Warsaw, Indiana 46581-0587 USA
POSSIBLE ADVERSE EFFECTS
Biomet Shoulder Joint Resurfacing Replacement Prostheses 1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histologi-

Attention Operating Surgeon cal reactions involving various sizes of macrophages and fibroblasts. The clinical significance
of this effect is uncertain, as similar changes may occur as a precursor to or during the
DESCRIPTION healing process. Particulate wear debris and discoloration from metallic and polyethylene
Biomet manufactures resurfacing shoulder components intended for partial or total joint arthro- components of joint implants may be present in adjacent tissue or fluid. It has been reported
plasty. Shoulder joint replacement components include: humeral resurfacing heads and glenoid that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be
components. Components are available in a variety of sizes for primary procedures only. a result of loosening of the implant.
2. Early or late postoperative, infection, and allergic reaction.
Biomet Shoulder Joint Resurfacing components are intended for use in cemented and non- Intraoperative bone perforation or fracture may occur, particularly in the presence of poor
cemented applications. bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption,
or while inserting the device.
Materials: CoCrMo Alloy 3. Loosening or migration of the implants can occur due to loss of fixation, trauma, malalign-
Humeral Resurfacing Heads Ultra High Molecular Weight Polyethylene ment, bone resorption, and/or excessive activity.
Glenoid Components (UHMWPE)/ CoCrMo Alloy/Titanium Alloy 4. Periarticular calcification or ossification, with or without impediment of joint mobility.
Titanium Alloy 5. Inadequate range of motion due to improper selection or positioning of components.
Porous Coating Titanium Alloy/CoCrMo Alloy 6. Undesirable shortening of limb.
Humeral Base Plates Titanium Alloy 7. Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and
MacroBond™ fibrous tissue laxity can also contribute to these conditions.
8. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity,
INDICATIONS malalignment, trauma, non-union, or excessive weight.
Resurfacing heads are indicated for the following conditions where the humeral head and neck 9. Fretting and crevice corrosion can occur at interfaces between components.
are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which 11. Wear and/or deformation of articulating surfaces.
is necessary for proper functioning and dislocation resistance: 12. Accelerated wear of glenoid articular cartilage.
13. Intraoperative or postoperative bone fracture and/or postoperative pain.

1. Non-inflammatory degenerative joint disease including, osteoarthritis and avascular necro- STERILITY
sis. Prosthetic components are sterilized by exposure to a minimum dose of 25 kGy of gamma radia-
tion. Do not resterilize. Do not use any component from an opened or damaged package. Do
2. Rheumatoid arthritis not use implants after expiration date.
3. Correction of functional deformity
4. Reconstructable Rotator Cuff Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
5. Treatment of acute fracture of the humeral head
6. Traumatic arthritis

Patient selection factors to be considered include: 1) need to obtain pain relief and improve func- Manufacturer: Biomet Manufacturing, Inc.
tion, 2) ability and willingness of the patient to follow instructions, including control of weight and 56 East Bell Drive
activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full Warsaw, IN 46582
skeletal maturity.
Authorized Representative: Biomet Merck, Ltd.
CONTRAINDICATIONS Waterton Industrial Estates,
Absolute contraindications include: infection, sepsis, and osteomyelitis. Bridgend, South Wales
Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders CF31 3XA, U.K.
who are incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may im-
pair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant 0086
site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
7) Revision procedures where other devices or treatments have failed.

WARNINGS
Improper selection, placement, positioning, alignment and fixation of the implant components
may result in unusual stress conditions which may lead to subsequent reduction in the service life
of the prosthetic components. Malalignment of the components or inaccurate implantation can
lead to excessive wear and/or failure of the implant or procedure. Inadequate preclosure cleaning
(removal of surgical debris) can lead to excessive wear. Improper preoperative or intraoperative
implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue
fracture and/or excessive wear. Thoroughly clean and dry tapers prior to attachment of modu-
lar head component to avoid crevice corrosion and improper seating. Use clean gloves when
handling implants. Laboratory testing indicates that implants subjected to body fluids, surgical
debris or fatty tissue have lower adhesion strength to cement than implants handled with clean
gloves. Do not modify implants. The surgeon is to be thoroughly familiar with the implants and
instruments prior to performing surgery.

Removal of metallic debris and other surgical debris at the implant site is critical to minimize wear
of the implant articular surfaces.

Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and
restoring function for many patients. While these devices are generally successful in attaining
these goals they cannot be expected to withstand the activity levels and loads of normal healthy
bone and joint tissue.

Accepted practices in postoperative care are important. Failure of the patient to follow postop-
erative care instructions involving rehabilitation can compromise the success of the procedure.
The patient is to be advised of the limitations of the reconstruction and the need for protection of
the implants from full load bearing until adequate fixation and healing have occurred. Excessive
activity, trauma and excessive weight and excessive weight bearing have been implicated with
premature failure of the implant by loosening, fracture, and/or wear. Loosening of the implants
can result in increased production of wear particles, as well as accelerate damage to bone making
successful revision surgery more difficult. The patient is to be made aware and warned of general
surgical risks, possible adverse effects as listed, and to follow the instructions of the treating
physician including follow-up visits.

PRECAUTIONS
Specialized instruments are designed for Biomet joint replacement systems to aid in the accurate
implantation of the prosthetic components. The use of instruments or implant components from
other systems can result in inaccurate fit, sizing, excessive wear and device failure. Intraoperative
fracture or breaking of instruments has been reported. Surgical instruments are subject to wear
with normal usage. Instruments which have experienced extensive use or excessive force are
susceptible to fracture. Surgical instruments should only be used for their intended purpose.
Biomet recommends that all instruments be regularly inspected for wear and disfigurement.

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package
insert, please contact Biomet at the contact information provided herein.

20

Biomet Orthopedics, Inc. 01-50-0992 POSSIBLE ADVERSE EFFECTS
56 E. Bell Drive Date: 09/05 1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histologi-
P.O. Box 587
Warsaw, Indiana 46581-0587 USA cal reactions involving various sizes of macrophages and fibroblasts. The clinical significance
of this effect is uncertain, as similar changes may occur as a precursor to or during the
Biomet® Copeland™ Extended Articulating Surface (EAS) healing process. Particulate wear debris and discoloration from metallic and polyethylene
Shoulder Joint Resurfacing Prostheses components of joint implants may be present in adjacent tissue or fluid. It has been reported
that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be
ATTENTION OPERATING SURGEON a result of loosening of the implant.
2. Early or late postoperative infection and allergic reaction.
DESCRIPTION 3. Intraoperative bone perforation or fracture may occur, particularly in the presence of poor
Biomet manufactures resurfacing shoulder components intended for hemi or total shoulder bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption,
arthroplasty. Resurfacing shoulder joint replacement components include: humeral resurfac- or while inserting the device.
ing heads and glenoid components. Components are available in a variety of sizes for primary 4. Loosening or migration of the implants can occur due to loss of fixation, trauma, malalign-
procedures only. ment, bone resorption, and excessive activity.
5. Periarticular calcification or ossification, with or without impediment of joint mobility.
Materials CoCrMo Alloy 6. Inadequate range of motion due to improper selection or positioning of components.
Humeral Resurfacing Heads Ultra High Molecular Weight Polyethylene 7. Undesirable shortening of limb.
Glenoid Components (UHMWPE)/CoCrMo Alloy/Titanium Alloy 8. Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and
Hydroxyapatite fibrous tissue laxity can also contribute to these conditions.
Titanium Alloy 9. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity,
MacroBond® Calcium Phosphate malalignment, trauma, non-union, or excessive weight.
Hydroxyapatite 10. Fretting and crevice corrosion can occur at interfaces between components.
11. Wear and/or deformation of articulating surfaces.
INDICATIONS 12. Accelerated wear of glenoid articular cartilage.
The Copeland™ Extended Articulating Surface (EAS) Resurfacing Heads are indicated for 13. Postoperative bone fracture and pain.
hemi- or total shoulder replacement in patients with massive, irreparable rotator cuff tears and
arthritis. Specific indications include: STERILITY
Prosthetic components are sterilized by exposure to a minimum dose of 25kGy of gamma radia-
1. Cuff tear arthropathy. tion. Do not resterilize. Do not use any component from an opened or damaged package. Do
2. Difficult clinical management problems where other methods of treatment may not be suit- not use implants after expiration date.

able or may be inadequate. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Implants with Interlok®/hydroxyapatite are cleared for uncemented applications. Implants with Authorized Representative: Biomet U.K., Ltd.
MacroBond® and MacroBond® coating with hydroxyapatite are cleared for cemented and unce- Waterton Industrial Estates,
mented applications; however, cement should only be applied to the surfaces that do not contain Bridgend, South Wales
hydroxyapatite coating (i.e. stem). CF31 3XA, U.K.

Patient selection factors to be considered include: 1) need to obtain pain relief and improve func- 0086
tion, 2) ability and willingness of the patient to follow instructions, including control of weight and
activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full
skeletal maturity.

CONTRAINDICATIONS
Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders
who are incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may im-
pair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant
site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
7) revision procedures where other devices or treatments have failed, 8) intact or reconstructable
rotator cuff and 9) lack of functional deltoid.

WARNINGS
Improper selection, placement, positioning, alignment and fixation of the implant components
may result in unusual stress conditions which may lead to subsequent reduction in the service
life of the prosthetic components. The use of a glenoid prosthesis in patients with cuff tear ar-
thropathy could increase the risk of glenoid component loosening due to non-anatomic loading
conditions. Malalignment of the components or inaccurate implantation can lead to excessive
wear and/or failure of the implant or procedure. Inadequate preclosure cleaning (removal of surgi-
cal debris) can lead to excessive wear. Improper preoperative or intraoperative implant handling
or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture and/
or excessive wear. Do not modify implants. The surgeon is to be thoroughly familiar with the
implants and instruments, prior to performing surgery.

Biomet® joint replacement prostheses provide the surgeon with a means of reducing pain and
restoring function for many patients. While these devices are generally successful in attaining
these goals, they cannot be expected to withstand the activity levels and loads of normal healthy
bone and joint tissue.

Accepted practices in postoperative care are important. Failure of the patient to follow postop-
erative care instructions involving rehabilitation can compromise the success of the procedure.
The patient is to be advised of the limitations of the reconstruction and the need for protection of
the implants from full load bearing until adequate fixation and healing have occurred. Excessive
activity, trauma and weight gain have been implicated with premature failure of the implant by
loosening, fracture, and/or wear. Loosening of the implants can result in increased production of
wear particles, as well as accelerate damage to bone making successful revision surgery more
difficult. The patient is to be made aware and warned of general surgical risks, possible adverse
effects as listed, and to follow the instructions of the treating physician including follow-up visits.

PRECAUTIONS
Specialized instruments are designed for Biomet® joint replacement systems to aid in the ac-
curate implantation of the prosthetic components. The use of instruments or implant compo-
nents from other systems can result in inaccurate fit, sizing, excessive wear and device failure.
Intraoperative fracture or breaking of instruments has been reported. Surgical instruments are
subject to wear with normal usage. Instruments, which have experienced extensive use or
excessive force, are susceptible to fracture. Surgical instruments should only be used for their
intended purpose. Biomet recommends that all instruments be regularly inspected for wear and
disfigurement.

Do not reuse implants. While an implant may appear undamaged, previous stress may have
created imperfections that would reduce the service life of the implant. Do not treat patients with
implants that have been, even momentarily, placed in a different patient.

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package
insert, please contact Biomet at the contact information provided herein.

21

Biomet Orthopedics, Inc. 01-50-0972 POSSIBLE ADVERSE EFFECTS
56 E. Bell Drive Date: 4/02 1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histologi-
P.O. Box 587
Warsaw, Indiana 46581-0587 USA cal reactions involving various sizes of macrophages and fibroblasts. The clinical significance
of this effect is uncertain, as similar changes may occur as a precursor to or during the
Biomet Copeland Hydroxyapatite Coated Shoulder Joint Resurfacing Prostheses healing process. Particulate wear debris and discoloration from metallic and polyethylene
components of joint implants may be present in adjacent tissue or fluid. It has been reported
Attention Operating Surgeon that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be
a result of loosening of the implant.
DESCRIPTION 2. Early or late postoperative, infection, and allergic reaction.
Biomet manufactures resurfacing shoulder components intended for partial or total joint arthro- Intraoperative bone perforation or fracture may occur, particularly in the presence of poor
plasty. Resurfacing shoulder joint replacement components include: humeral resurfacing heads bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption,
and glenoid components. Components are available in a variety of sizes for primary procedures or while inserting the device.
only. 3. Loosening or migration of the implants can occur due to loss of fixation, trauma, malalign-
ment, bone resorption, and excessive activity.
MATERIALS CoCrMo Alloy 4. Periarticular calcification or ossification, with or without impediment of joint mobility.
Humeral Resurfacing Heads Ultra High Molecular Weight Polyethylene 5. Inadequate range of motion due to improper selection or positioning of components.
Glenoid Components (UHMWPE)/CoCrMo Alloy/Titanium Alloy 6. Undesirable shortening of limb.
Titanium Alloy 7. Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and
MacroBond™ Calcium Phosphate fibrous tissue laxity can also contribute to these conditions.
Hydroxyapatite 8. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity,
malalignment, trauma, non-union, or excessive weight.
INDICATIONS 9. Fretting and crevice corrosion can occur at interfaces between components.
The Copeland™ Resurfacing Heads are indicated for the following conditions where the humeral 10. Wear and/or deformation of articulating surfaces.
head and neck are of sufficient bone stock and there is presence of an intact or reconstructable 11. Accelerated wear of glenoid articular cartilage.
rotator cuff, which is necessary for proper functioning and dislocation resistance: 12. Postoperative bone fracture and pain.

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. STERILITY
2. Rheumatoid arthritis Prosthetic components are sterilized by exposure to a minimum dose of 25kGy of gamma radia-
3. Correction of functional deformity tion. Do not resterilize. Do not use any component from an opened or damaged package. Do
4. Reconstructable rotator cuff not use implants after expiration date.
5. Treatment of fractures of the humeral head
6. Traumatic arthritis Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

For uncemented use only. Authorized Representative: Biomet Merck, Ltd.
Waterton Industrial Estates,
Patient selection factors to be considered include: 1) need to obtain pain relief and improve func- Bridgend, South Wales
tion, 2) ability and willingness of the patient to follow instructions, including control of weight and CF31 3XA, U.K.
activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full
skeletal maturity.

CONTRAINDICATIONS
Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders
who are incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may im-
pair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant
site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
7) Revision procedures where other devices or treatments have failed.

WARNINGS
Improper selection, placement, positioning, alignment and fixation of the implant components
may result in unusual stress conditions which may lead to subsequent reduction in the service life
of the prosthetic components. Malalignment of the components or inaccurate implantation can
lead to excessive wear and/or failure of the implant or procedure. Inadequate preclosure cleaning
(removal of surgical debris) can lead to excessive wear. Improper preoperative or intraoperative
implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue
fracture and/or excessive wear.

Therefore, to avoid crevice corrosion and improper seating thoroughly clean and dry tapers
prior to attachment of modular head component. Do not modify implants. The surgeon is to
be thoroughly familiar with the implants and instruments, prior to performing surgery. Removal
of metallic debris and other surgical debris at the implant site is critical to minimize wear of the
implant articular surfaces.

Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and
restoring function for many patients. While these devices are generally successful in attaining
these goals they cannot be expected to withstand the activity levels and loads of normal healthy
bone and joint tissue.

Accepted practices in postoperative care are important. Failure of the patient to follow postop-
erative care instructions involving rehabilitation can compromise the success of the procedure.
The patient is to be advised of the limitations of the reconstruction and the need for protection of
the implants from full load bearing until adequate fixation and healing have occurred. Excessive
activity, trauma and weight gain have been implicated with premature failure of the implant by
loosening, fracture, and/or wear. Loosening of the implants can result in increased production of
wear particles, as well as accelerate damage to bone making successful revision surgery more
difficult. The patient is to be made aware and warned of general surgical risks, possible adverse
effects as listed, and to follow the instructions of the treating physician including follow-up visits.

PRECAUTIONS
Specialized instruments are designed for Biomet joint replacement systems to aid in the accurate
implantation of the prosthetic components. The use of instruments or implant components from
other systems can result in inaccurate fit, sizing, excessive wear and device failure. Intraoperative
fracture or breaking of instruments has been reported. Surgical instruments are subject to wear
with normal usage. Instruments, which have experienced extensive use or excessive force, are
susceptible to fracture. Surgical instruments should only be used for their intended purpose.
Biomet recommends that all instruments be regularly inspected for wear and disfigurement.

Do not reuse implants. While an implant may appear undamaged, previous stress may have
created imperfections that would reduce the service life of the implant. Do not treat patients with
implants that have been, even momentarily, placed in a different patient.

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package
insert, please contact Biomet at the contact information provided herein.

22

Notes:

23

Notes:

24

Notes:

All trademarks herein are property of Biomet, Inc. or its subsidiaries unless
otherwise indicated.
PDSII® and Monocryl® are trademarks of Ethicon, Inc.
Stablecut® is a trademark of Synvasive Technology, Inc.
This material is intended for the sole use and benefit of the Biomet sales force and
physicians. It is not to be redistributed, duplicated or disclosed without the express
written consent of Biomet.
For product information, including indications, contraindications, warnings, precautions
and potential adverse effects, see the package insert herein and Biomet’s website.

P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501
©2008 Biomet Orthopedics • www.biomet.com
Form No. BOI0252.1 • REV113008