The information contained in this document is intended for healthcare professionals only.

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1 The information contained in this document is intended for healthcare professionals only.

2 Now with Tobramycin! Simplex P Bone Cement the #1 Bone Cement Unmatched strength and handling Uncompromising clinical success Now Pre-blended with Tobramycin the #1 Antibiotic of Choice

3 Blending Experience and Science For over 40 years, Simplex P Bone Cement has earned the trust and confidence of tens of thousands of surgeons. With over 18 million doses implanted, no other bone cement can match the experience of Simplex P Bone Cement. Hundreds of articles in respected, peer-reviewed journals confirm the outstanding performance of Simplex P Bone Cement. CEMENT CONFIDENCE AND PERFORMANCE 1958 Simplex C Cement introduced in Europe Simplex P Bone Cement introduced in Europe Simplex P Bone Cement first to receive FDA approval in US for total hip arthroplasty Simplex P Bone Cement approved for total knee arthroplasty in US Simplex P Antibiotic Bone Cement with Erythramycin and Colistin introduced in Europe Simplex P Bone Cement* approved for use in pathological fractures and general prosthetic fixation Simplex P Bone Cement with Tobramycin introduced in Europe. IN ONE BOX At the heart of this illustrious history is the science behind the success of Simplex P Bone Cement a unique chemical composition that has become the orthopaedic standard by which other bone cements are measured: 75% methylmethacrylate-styrene copolymer 15% polymethylmethacrylate 10% barium sulfate Simplex P Bone Cement provides the right ingredients in the right formula, balancing unrivaled strength with consistent handling for dependable intraoperative and long-term clinical results Simplex P Bone Cement with Tobramycin introduced in US. *See package insert for full prescribing information.

4 Blending Preference and Consistency Tobramycin is the antibiotic-of-choice for more than 75% of orthopaedic surgeons in the US 1 for several important reasons: Ability to withstand exothermic temperatures of polymerizing cement Low allergy potential versus cephalosporins 2 Excellent safety profile Proven elution from Simplex P Bone Cement 3,4,5 Broad spectrum antibiotic Used safely for over 20 years in orthopaedics 6,7 Other Vancomycin Gentamicin With pre-blended Simplex P Bone Cement with Tobramycin, surgeons can be confident that the tobramycin is being optimally delivered to the patient. Commercial blending also ensures that the tobramycin is evenly distributed throughout the mixture, and that the mixture is consistently smooth. Cephalosporin More than one antibiotic commonly used Antibiotic of Choice for use with Bone Cement 1

5 Blending Efficiency and Convenience In one step, Simplex P Bone Cement with Tobramycin gives surgeons the strength of Simplex PBone Cement plus the convenience of tobramycin without the delay, hassle, or potential inconsistencies associated with mixing intraoperatively. CEMENT STRENGTH AND HANDLING IN ONE STEP Simplex P Bone Cement with Tobramycin is indicated for the fixation of prostheses to living bone in the second stage of a twostage revision for total joint arthroplasty. It is manufactured, blended, and tested to ensure optimal consistency of the mixture, which is comprised of 40g of Simplex P Bone Cement powder plus 1g of tobramycin. The liquid monomer portion of Simplex P Bone Cement is unchanged, maintaining the original Simplex P Bone Cement formula. As a result, the superior mechanical properties surgeons expect with Simplex P Bone Cement are inherent in Simplex P Bone Cement with Tobramycin. The proprietary formula and manufacturing process of Simplex P Bone Cement impart excellent viscosity characteristics, which result in superior fatigue 8,9 and shear strength. 10 Unlike high-viscosity bone cements, Simplex P Bone Cement penetrates deeper into cancellous bone for consistent fixation performance. 10 The controlled addition of tobramycin powder does not alter the unsurpassed mechanical properties of Simplex P Bone Cement. 11,12 2

6 Fatigue Cycles to Failure Tested at 20MPa* and 3 cycles/second. Internal mechanical testing confirms that fatigue strength is unaffected by the addition of 1g. tobramycin. 15 Shear Strength at Cement-to-Bone Interface (MPa) Tests prove Simplex P withstands nearly 20% more shear stress at the cement-to-bone interface as Palacos. 10 Handling Properties The handling properties of Simplex P with Tobramycin are unchanged from those of Simplex P Bone Cement. 15 *Note: 1 MPa (megapascal) = 145psi. 3

7 Blending Control and Capability When antibiotics are blended with bone cement, serum levels are controlled by the degree of antibiotic release. CEMENT SAFETY AND RESULTS IN ONE PRODUCT Tobramycin elutes from Simplex P Bone Cement and is concentrated locally. Low serum levels are maintained, minimizing the potential for toxicity and associated adverse side effects. In pre-clinical and clinical studies with Simplex P Bone Cement with Tobramycin, systemic tobramycin levels remained well below the toxic threshold. 4,13,14 Confidence and Performance Simplex P Bone Cement with Tobramycin is the perfect blend offering surgeons the confidence of their number-one bone cement plus their first-choice antibiotic. For experience, strength, consistency, and dependability, no other bone cement comes close to Simplex P Bone Cement with Tobramycin. 4

8 Clinical Elution from Simplex P Bone Cement with Tobramycin 13,14 Simplex P Bone Cement with Tobramycin vs. Palacos with Gentamicin Release 15

9 The most reliable, predictable, and trusted bone cement. References 1. Fish DN, Hoffman HM, Danziger LH. Antibiotic-impregnated cement use in US hospitals. Am J Hosp Pharm. 1992;49: Popham GJ, Mangino P, Seligson D, Henry SL. Antibiotic-impregnated beads. Part II: Factors in antibiotic selection. Orthop Rev Apr; 20(4): Brien WW, Salvati EA, Klein R, Brause B, Stern S. Antibiotic impregnated bone cement in total hip arthroplasty. Clin Orthop, 1993;296: Nijhof M, Dhert W, Tillman P, Verbout A, Fleer A. Release of tobramycin-containing bone cement in bone and serum of rabbits. J Mat Sci Mat Med. 1997;8(12): Scott CP, Higham PA, Dumbleton JH. Effectiveness of bone cement containing tobramycin: An in vitro susceptibility study of 99 organisms found in infected joint arthroplasty. J Bone Joint Surg (Br).1999;81-B: Heck D, Rosenberg A, Schink Ascani M, Garbus S, Kiewitt T. Use of Antibiotic-impregnated cement during hip and knee arthroplasty in the United States. J of Arthrop. 1995:10(4): Soto Hall R, Saenz L, Tavernetti R, Cabaud HE, Cochran TP. Tobramycin in bone cement. An in-depth analysis of wound, serum, and urine concentrations in patients undergoing total hip revision arthroplasty. Clin Orthop. 1983, May(175): Linden U. Fatigue properties of bone cement: Comparison of mixing techniques. Acta Orthop Scand. 1989:60(4): Davies J, Jasty M, O Conner D, Burke DW, Harrigan T, Harris W. The effect of centrifuging bone cement. J Bone Joint Surg (BR). 1989;71-B: MacDonald W, Phil M, Aust MIE, Swarts E, Beaver R. Penetration and shear strength of cement-bone interfaces in vivo. Clin Orthop Rel Res 1993;286: Murray WR, Use of antibiotic-containing bone cement. Clin Orthop Rel Res 1984 Nov(190): Davies JP, Harris WH. Effect of hand mixing tobramycin on the fatigue strength of Simplex P. J Biomed Mater Res 1991;25(3): Sterling GJ, Potter JM, Koerbin G, Crawford S, Crawford R, The pharmacokinetics of Simplex Tobramycin Bone Cement. A Study investigating the elution characteristics of Simplex Tobramycin Bone Cement in total hip replacement. J Bone Joint Surg (Br) 14. Physicians Desk Reference Edition 54, Medical Economics Company, Inc., Montvale NJ. 2000; Data on file at Howmedica Osteonics Stryker is a registered trademark of Stryker Corporation. Simplex P Bone Cement is a trademark of Howmedica Osteonics Corp. Palacos is not a registered trademark of Howmedica Osteonics Corp. Howmedica Osteonics 2003 Lit. No. LSPTB 2M 6/03 MC/ITP C Printed in USA on recycled paper. howost.com