Several years ago, our competitors introduced highly crosslinked polyethylene (HXLP). Biomet chose not to follow that path. Questions arose

regarding the mechanical and clinical properties of HXLP offered by some of our competitors, many of which have been borne out by

clinical reports.

1. Lab testing indicated lower fatigue strength and increased brittleness.1–4

2. Lab testing indicated the potential for severe oxidation resulting from

certain types of processing methods.5

3. Short-term retrievals showed evidence of premature surface cracking

in some cases.6

ArComXL TM Polyethylene:A New Way to Process Highly Crosslinked Polyethylene

Retrieval analysis of some HXLPs shows evidence of surface cracking and microtears, the cause of which may be attributed to decreased fatigue strength.12,13

White banding indicative of severe oxidation has been observed in several HXLP retrievals at short-term follow-up.14

Cracks

2

ArComXL TM 2nd generationHXLP addresses the concerns associated with 1st generation HXLP by providing:

• High Fatigue Strength• Extreme Oxidative Stability• Similiar Particle Size to ArCom® Polyethylene• A Solid Clinical Heritage

ArCom®

33 kGy Irradiation15

ArComXL™50 kGy

Irradiation15

HXLP 100 kGyIrradiation16

HXLP 50 kGyIrradiation16

Crac

k G

row

th R

esis

tanc

e (M

Pa-m

^.5)

1.8

1.3

.9.7

Many highly crosslinked polyethylene processing methods lead to mechanical weakening of the material. The patented processing method of ArComXL™ maintains higher resistance to crack propagation than 1st generation HXLPs.

3

Before � ArCom®

Polyethylene, addressing the performance questions presented in the literature surrounding other HXLP.

Since 1993, no other attempt at polyethylene

improvement has equaled the benefits of isostatic

compression molded ArCom® Polyethylene. Many

orthopedic surgeons regard ArCom® Polyethylene as the

gold standard among modern polyethylene bearings.

ArComXL™ is the only highly crosslinked polyethylene built

on this clinical heritage. ArComXL™ has demonstrated

in laboratory studies a 47%–64% decrease in volumetric

wear rate, a 30% increase in ultimate tensile strength,

similiar wear–particle shape and size, and no measurable

oxidation under accelerated aging.15,17

ArCom® Polyethylene

8 Year Clinical Follow-Up Zero Osteolysis19 40% Wear Reduction18

Conventional Poly18 ArCom®18 ArComXL™15

Volu

met

ric

Wea

r (m

m3 /

yr)

40% Reduction

47% Reduction

4

ArComXL TM Polyethylene

...47–64% Decrease in Volumetric Wear Rate, High Strength, and No Measurable Oxidation.15, 17

36mm heads available with ArComXL™ liners offer high range of motion and low wear potential.

5

ArCom® Isostatic Compression Molding: A Consolidated Foundation

Pure, consolidated polyethylene barstock, ready to be machined into ArCom® Polyethylene liners or further processed into ArComXL™ Polyethylene.

Step 1: Flexible tubes are filled with starting resin and sealed in preparation for water compaction.

Step 2: Isostatic water pressure is applied to the sealed flexible tube, which forms the resin into a bar shape.

Step 4: Green bars are now packaged in foil pouches, repeatedly flushed with argon gas, and a vacuum is drawn on the foil pouches.

Step 3: The shaped resin, or “green bars,” are now 70% consolidated. Heat and more intense pressure are still required for full consolidation.

Step 5: The vacuum sealed bars are now placed in the hot isostatic compression chamber and are subjected to 10 hours of carefully controlled heat and argon gas pressure.

Step 6: Laser candling inspection is used to ensure that ArCom® bars pass stringent consolidation standards.

6

Only Biomet controls all aspects of its

polyethylene processing

SolidSolid

ArComXL TM Processing Steps

8

ArCom® Barstock 50 kGy Gamma Irradiation

Below Melt Temp. Pre-Heat

Solid State Deformation

Stress Relief Acetabular Liner Machining

Non-EnergeticSterilization

High Wear Resistance, High Strength, and High Oxidative Stability

Free Radicals

Crosslink Bonds

Cracks due to Oxidation

Gamma irradiation increases the level of crosslink bonds in polyethylene. This is beneficial to wear resistance, but produces free radicals inside the polyethylene. If left untreated these free radicals may increase the oxidation potential of polyethylene when exposed to air.

Solid State Deformation enables high levels of crosslinking without sacrificing the mechanical strength or increasing the risk of

o�

residual free radicals, a concern with higher doses of irradiation. The entire process

takes place below the melt temperature of polyethylene, preserving the

mechanical strength. The Solid State Deformation “cannon” (see page 10)

quenches residual free radicals through a low heat process which,

unlike other 1st generation processes, does not involve melting. This

patented process does not decrease the mechanical strength or

change the crystallinity of the polyethylene.17

StrengthStrength

Longitudinal Polymer Orientation (LPO): Directionally Engineered Polyethylene

LPO

ArComXL ™ is the only HXLP to be Directionally Engineered through LPO

10

• Directionally Orients the Polymer Chains Along the Longitudinal Axis

• Provides High Strength in the Direction of Wear

• Assists in Neutralizing Free Radicals

Solid State De�

Longitudinal Polymer Orientation (LPO). As a result of Solid State Deformation, LPO directionally aligns the polymer chains along the longitudinal axis of

the polyethylene barstock. This provides the highest level of mechanical strength in the direction that wear occurs.

DirectionDirection

A Clinical Heritage of Strength, Wear Reduction, and Low Osteolysis

ArComXL™ Polyethylene is the first of the 2nd generation HXLPs to

have high mechanical strength and high resistance to oxidation.

ArComXL™ also provides a 47 to 64% reduction in volumetric wear

rate over ArCom® Polyethylene.15 Extensive independent testing has

been conducted on the mechanical strength of the material and

the wear particle size, shape, and distribution—all of which are

found to be consistent with ArCom® Polyethylene.17

0

5E+10

1E+11

2E+11

2E+11

3E+11

3E+11

4E+11

4E+11

0 0.2 0.4 0.6 0.8 1 1.2

ArCom XL

ArCom

Esti

mat

ed N

umbe

r of

Par

ticl

es

Particle Size (microns)

ArComXL™ ArCom®

ArCom®

33 kGy Irradiation17

ArComXL™50 kGy

Irradiation17

HXLP 100 kGyIrradiation21

HXLP 50 kGyIrradiation20

Tens

ile S

tren

gth(

mPa

)

47

60

3433

ArComXL™ is built on the strength of ArCom® Polyethylene, which maintains high mechanical strength specifically in the longitudinal axis compared to other highly crosslinked polyethylenes.17, 20, 21

ArComXL™ has similar wear particle shape and size distribution when compared to ArCom® polyethylene with a reduction in the estimated amount of particles in the 0.2 to 0.4 micron range.17 Concerns have been raised about the osteolytic potential of smaller wear particles.9, 10

12

DurabilityDurability

Biomet Orthopedics, Inc. 01-50-0966P.O. Box 587 Date: 12/0456 East Bell DriveWarsaw, Indiana 46581 USA

Biomet Hip Joint Replacement ProsthesesArComXLTM Highly Crosslinked Polyethylene

Attention Operating Surgeon

DescriptionAcetabular liners are composed of UHMWPE and are manufactured into various designs and sizes. The acetabular liners are utilized with other hip prostheses as part of a total joint system. Total hip joint prostheses include: femoral stems, femoral heads, acetabular shells, and acetabular liners. Components are available in numerous designs and sizes intended for primary and/or revision applications. Specialty components that can be added to the total hip system include: acetabular screws, centering sleeves, and canal plugs.

MaterialsAcetabular Liners ArComXLTM highly crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) Indications 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty.

Cemented or uncemented applications.

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

ContraindicationsAbsolute 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 impair 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) vascular insufficiency, muscular atrophy, or neuromuscular disease.

WarningsImproper selection, placement, positioning, alignment and/or 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. Do not modify implants. The surgeon is to be thoroughly familiar with the implants and instruments prior to performing surgery.

1. Acetabular screws are to be fully seated to assure stable fixation and to avoid interference with the acetabular liner component.

2. Prior to seating the liner into the shell component, all surgical debris (tissue fragments, etc.) must be removed from the interior of the shell component, as debris may inhibit the locking mechanism from engaging and securing the liner into the shell component. 3. Care is to be taken to assure complete support of all parts of the device embedded in bone cement to prevent stress concentrations, which may lead to failure of the procedure. Complete preclosure cleaning and removal of bone cement debris, metallic debris, and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces. Implant fracture due to cement failure has been reported.

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 postoperative care instructions involving rehabilitation can compromise the success of the procedure. The patient is to be advised of the limitation 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/or 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.

PrecautionsSpecialized 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 that 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 placed in a different patient, even if momentarily.

Possible Adverse Effects 1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histological 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 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 that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant.

14

2. Early or late postoperative, infection, and allergic reaction. 3. Intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device. 4. Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity. 5. Periarticular calcification or ossification with or without impediment of joint mobility. 6. Inadequate range of motion due to improper selection or positioning of components. 7. Undesirable shortening of limb. 8. Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions. 9. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, and/or excessive weight. 10. Fretting and crevice corrosion can occur at interfaces between components. 11. Wear and/or deformation of articulating surfaces. 12. Trochanteric avulsion or non-union as a result of excess muscular tension, early weight bearing, or inadequate reattachment. 13. Problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy, too much femoral medialization or muscle deficiencies. 14. Postoperative bone fracture and pain.

SterilityProsthetic components are sterilized by exposure to one of the following methods:• Ethylene Oxide Gas (EtO)• Gas Plasma

References 1. Baker, D., et al., “Study of Fatigue Resistance of Chemical and Radiation Crosslinked Medical Grade UHMWPE,” JBMR 46:573–581, 1999. 2. Eberhardt, A., et al., “The Effects of Irradiation Level and Resin on Fatigue Crack Resistance in UHMWPE,” Society for Biomaterials, 2001. 3. Gomoll, A., et al., “Quantitative Measurement of the Morphology and Fracture Toughness of Radiation Crosslinked UHMWPE,” ORS, Feb. 2001. 4. Gillis, A., et al., “An Independent Evaluation of the Mechanical, Chemical, and Fracture Properties of UHMWPE Crosslinked by 34 Different Conditions,” ORS, Feb. 1999. 5. Muratoglu, et al., “Effect of Radiation, Heat, and Aging on In Vitro Wear Resistance of Polyethylene,” CORR Number 417, pp.253–262, December 2003. 6. Jasty, M., “Crosslinked Poly Podium Presentation,” 4th Annual Symposium on Alternative Bearing Surfaces in TJR, Maui, Hawaii, Sept. 2001. 7. Ries, M., “The New Polys: Bridges too Far?” Session XV, Current Concepts in Joint Replacement, Las Vegas, NV May 2001 8. Scott, et al.; “Wear Particle Analyses of Conventional and Crosslinked UHMWPE Tested in an Anatomic Hip Simulator,” 47 Annual Meeting of the Orthopaedic Research Society, San Francisco, CA Feb. 2001 9. Mabrey, J., et al., “Comparison of UHMWPE Particles in Synovial Fluid and Tissues from Failed THA,” Journal of Biomedical Materials Research 58:196–202, 2001. 10. Green, T., et al., “Effect of Size and Dose of Bone Resorption Activity of Macrophages by In Vivo Clinically Relevant UHMWPE Particles” Journal of Biomedical Materials Research 53: 490–497, 2000. 11. Halley, D., et al., “Recurrent Dislocation After Revision Total Hip Replacement with a Large Prosthetic Femoral Head” JBJS pg.827-30 Vol. 86A Number 4, April 2004. 12. Bradford, et al., “Wear and Surface Cracking in Early Retrieved Highly Cross-linked Polyethylene Acetabular Liners,” JBJS, Vol. 86-A, No. 6, June 2004. 13. Edidin, et al., “Wear Surface Analysis of Highly Crosslinked Acetabular Liners After Implantation.” June 12, 2001. www.uhmwpe.org/downloads/publications/edidin20010901.pdf. 14. Bhattacharyya, S., et al., “Severe In Vivo Oxidation In a Limited Series of Retrieved Highly Crosslinked UHMWPE Acetabular Components With Residual Free Radicals,” 50th Annual Meeting of the Orthopedic Research Society, Paper No:0276, March 2004. 15. Data on file at Biomet. 16. Baker, DA, Bellare, A, Pruitt, L: “The Effects of Degree of Crosslinking on the Fatigue Crack Initiation and Propagation Resistance of Orthopedic-Grade Polyethylene.” J Biomed Mater Res, 66A: 146–154, 2003. 17. Data Submitted for publication (Exponent). 18. Head, W., et al., “Comparison of Polyethylene Wear in Machined Versus Molded Polyethylene Liners in Ringloc® Acetabular Cups,” Texas Center for Joint Replacement, Plano, TX. 19. Head, W., et al., “Mechanical Properties and Clinical Evaluation of Isostatic Molded ArCom Polyethylene,” SICOT, August 2002, San Diego, CA. 20. Greer, K., et al., “The Effects of Raw Material, Irradiation Dose, and Irradiation Source on Crosslinking of UHMWPE,” ASTM STP 1445: Crosslinked and Thermally Treated UHMWPE for Joint Replacement, 2004. 21. Bhambri, S., et al., “The Effect of Aging on Mechanical Properties of Melt-Annealed Highly Crosslinked UHMWPE,” ASTM STP 1445: Crosslinked and Thermally Treated UHMWPE for Joint Replacement, 2004.

Do not resterilize. Do not use any component from an opened or damaged package. Do not use implants after expiration date.

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

Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet, Inc., P.O. Box 587, Warsaw, IN 46581 USA, Fax 574-372-1683.

Authorized Representative: Biomet, U.K., Ltd. Waterton Industrial Estates, Bridgend, South Wales CF31 3XA U.K.

0086

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.

15

This material is intended for the sole use and benefi t of the Biomet sales force and physicians. It is not to be redistributed, duplicated, or disclosed without the express written consent of Biomet.

ArCom® , ArComXL™ , and RingLoc® are trademarks of Biomet Manufacturing Corp.P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501

©2005 Biomet Orthopedics, Inc. All Rights Reserved • www.biomet.comForm No. Y-BMT-905R/041505/M

FDA Cleared Claim Statements

DrivenByEngineering

Hip Simulator WearThe Biomet ArComXL™ polyethylene acetabular inserts (Part no.: XL-105933) tested are isostatically compression molded highly crosslinked components (50kGy gamma irradiated under argon) that are sterilized in air by either gas plasma or ethylene oxide. ArComXL™ was compared to identical predicate polyethylene liners (Part No. 12-105893) that were machined from isostatically molded polyethylene that was subsequently gamma sterilized (25-40kGy) in argon. A side� 3/106 cycles) for ArComXL™ (EtO sterilized) when compared to the predicate device. All inserts in this study mate with either a 50 or 52mm acetabular shell, have a standard rim, a 32mm inner diameter, and a 4.75mm bearing thickness. Testing was performed under multiaxial hip joint simulation for fi ve (5) million cycles, using a Paul hip load profi le with a maximum load of 2.4kN, 32mm CoCr articulating heads, and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

Abrasive Hip Simulator Wear The Biomet ArComXL™ polyethylene acetabular inserts (Part No. XL-105933) tested�air by either gas plasma or ethylene oxide. ArComXL™ was compared to identical predicate polyethylene liners (Part No. 12-105893) that were machined from isostatically molded polyethylene that was subsequently gamma sterilized (25-40kGy) in argon. After 5 million cycles of hip simulator wear �conditions, the Biomet ArComXL™ (EtO sterilized) polyethylene acetabular insert (Part No. XL-105933) showed a 64% reduction in volumetric wear rate (109.8 opposed to 309.0mm3/106 cycles) when compared to the same acetabular inserts fabricated from the predicate polyethylene (Part No. 12-105893). These inserts mate with either a 50 or 52mm acetabular shell, have a standard rim, a 32mm inner diameter, and a 4.75mm bearing thickness. Testing was performed under multiaxial hip joint simulation for two (2) million cycles, using a Paul hip load profi le with a maximum load of 2.4kN, 32mm CoCr articulating heads, and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

Free RadicalsThe Biomet ArComXL™ polyethylene material tested is isostatically compression�ArComXL™ was compared to predicate polyethylen� The Biomet ArComXL™ (gas plasma sterilized) material, showed a 94% reduction in the number of free radicals (0.22x1015 compared to 3.82x1015 spins/g) versus the predicate polyethylene material. Testing was performed by an independent laboratory using Electron Spin Resonance (ESR). Results of in vitro free radical testing have not been shown to quantitatively predict oxidation resistance.

Oxidative StabilityThe Biomet ArComXL™ polyethylene material tested is isostatically compression�ArComXL™ was compared to predicate polyethylen� The Biomet ArComXL™ (gas plasma sterilized) material � ASTM F2003-00, which is designed to simulate several years of shelf-aging in air. In contrast, when the predicate material was removed fro�acclerated aging (oxidation index was greater than 1.1 at a depth of 1mm). Further, after acclerated aging the average ultimate load for all three ArComXL™ axes (gas plasma sterilized) remained higher than the peak load (31% higher; 91.8N vs. 70.2N); whereas, the ultimate load for the isotropic predicate material was signifi cantly less than the peak load (44% lower; 42.6N vs. 75.6N) as measured by small punch testing, ASTM F2183-02.

Mechanical StrengthThe Biomet ArComXL™ polyethylene material tested is isostatically compression�ArComXL™ was compared to predicate polyethylene � The Biomet ArComXL™ (EtO sterilized) material showed a 30% increase in ultimate tensile strength (from 47 MPa to 61 MPa) in the longitudinal axis versus the predicate polyethylene material. The tensile testing was performed per ASTM standard D638-02a using Type 5 tensile specimens.

Directionally Engineered Highly Crosslinked Polyethylene

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website.

Building on the long-standing clinical heritage of ArCom®

Polyethylene, Biomet is proud to introduce directionally engineered

Highly Crosslinked Polyethylene for total hip replacement.