Memorandum TO DePuy. Aunt Bea Team (Alternate Bearing) From Frank Bono Subject Date May 9. 1995 Meeting Minutes, April 22, 1995-Chicago O'Hare, 1st. Designing Surgeon Meeting Attendees: Paul Peters, M.D. Brian Haas, Andy Engh, MD. John Fanning, M.D. Frank Bono Steve Haas Phil Jenks Don McNulty Stacey Milionis Jeff Ondrla Steve Wentworth Tim Pruitt The following are meeting minutes obtained from the 1st. Alternate Bearing designing . surgeons meeting held at the Chicago O'Hare Hilton on April 22, 1995. The meeting agenda as well as overhead presentations are attached. Note, a few slides were also used in the presentation and they are notincluded in this memo. Ondrla: Haas, 3.: Pruitt: Bono: PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. The project objective was stated, noting that this is a research feasibility project The market outlook was mentioned, gave the overall impression that we should proceed quickly but very cautiously, also keep in mind unit cost. ln?vivo animal studies a possibility with various coatings? Ti and DLC (diamond like coating) is focus now, characterization of_scratch resistance very important. Wide variety of CoCr alloys out there, composition affecting performance. Coatings - adhesion concerns, scratch flaking Diamond coatings, DePuy sole rights to orthopaedic applications-00C Ceramics vs. poly vs. metal - same. biological response to submicron size particles regardless of material. . History ball bearing industry today could really help us out why tolerancing and lubrication is so important with hard material on hard material contact. Dr. Fanning: Used Sivash system (metal-on-metal) with Doug Noiles in late 60's early 70?s, no metal debris 16 yr post-op. Dr. Fenning: Sulzer may have been down path of tolerances of bearing industry and may have found it is not necessary to have as hearing industry? 5" a CORANGE company DEPUY063303035 Jenks: Milionis: Wentworth: Dr. B. Haas: Dr. Peters: Dr. Fenning: Dr. A. Engh: Ondrla: PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. Dr. Peters: We need to be cautious of the legal/litigation issues and lawyers perception of metal debris and metal?ion release. Discussion of-grinders, vibratory finishers, reprOducible-quality products. Review of options and issues, where are we going?, evaluate all three options, push technology, look at other industries Metal-on-metal Class device, PMA required, takes 5 yrs, would we try 510k first? we would do 510k concurrently with Proponent of Metal-on-metal, not a fan of ceramic, thinks coatings are too far into future. What kind of company focus does DePuy have on this project? Pruitt/Bonofream: assured Dr. Haas that we are committed to this project, have a strong team, have resources and have upper management support. Spent time in England with Watson Farrar, Fractured cement and cup loosening were modes of failure. Toxicity Ion releasea fact of metals, saw no tumors with Farrar but these issues must be addresses Doug Noiles is working with JMP on SRN (Sivash Revised Noiles Suggested we look at history of Sivash. Biomet had a Metal-on-metal couple in early 70?s called Sparboro, Fenning put a couple of these in. Talked about U.S. being behind Europe in ceramics, stated that maybe enhanced poly and and ceramic heads may be direction to go? Spoke of goals maybe being 20 yr results with minimal lysis? 90% of orthopods do less than 30 joints/yr. that is our market! Milionis/Bono: Let Dr. Fenning know that work on Zirconia/Hylamer (wear testing was being done at DePuy Int. Leeds. Not scope of this project. Emphasized that young patient is. our market, we must eliminate debris, cost of implant should be of concern in tod-ays market, let?s decrease modularity, can we begin to guarantee 10 years of implant life?, simple to put in. Asked surgeons to supply us with numbers that they can be reached, office hours, and good times for contact. Next Surgeon meeting is scheduled for Saturday Sept. 30, Hilton Head, SC. (DePuy Annual Meeting). DEPUY063303036 Distribution: Manufacturing - Phil Jenks Sam Fryback Quality - Brian Motter - Jeff Ondrla Dick Tarr Tim Pruitt I Don McNulty Clinical Research - Steve Peoples Marketing - Steve Haas Art O'Neal PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY063303037 - AGENDA DEPUY ALTERNATIVE BEARING SURGEON INTRODUCTORY DESIGN MEETING Chicago O?Hare Hilton Saturday, April 22nd, 1995 Designing 0 Andy Engh, Jr., MD. Surgeons: John B.-Fenning, M.D. Brian D. Haas, MD. Paul C. Peters, Jr., MD. DePuy: Frank Bono - Senior Product Development Engineer Steve Haas - Marketing Product Manager Phil Jenks Manufacturing Engineering Don McNulty - Manager Surface and Coating Research Stacey Milionis - Senior Product Development Engineer Jeff Ondrla - Hip 81 Extremities Group Product Development Manager Steve Wentworth Manager Clinical Research Tim Pruitt - Manager Material Technologies 10:15 am. Arrive I Introduction 10:30 am. Jeff Ondrla I Steve Haas - Engineering Objective I Market Potential 10:40 am. Tim Pruitt - Manufacturing Terminology. Design issues 1 1:00 am. Frank Bono - Alternate Bearing History 11:10 am. Frank Bono - Orthopaedic Manufacturers Capabilities Today Competition 11:20 am. Phil Jenks - Manufacturing Technology I Issues I 11:25 am. Stacey Milionis - Options issues: Ceramics Metals Diamond Coatings 1 1 :45 am. Steve Wentworth - Regulatory Issues 11:55 am. Surgeon Presentations - Why is an Alternate Bearing Mat'l of interest to You? (Approximately 10-min each) 12:35 pm. Jeff Ondrla - Objectives I Goals Progression Meetings 12:40 pm. Open Forum - Lunch 1:30 pm. Close PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY063303038 BEARING COUPLES - I. BEARING COUPLE OPTIONS II. CURRENT ISSUES FAILURE ANALYSIS IV. WHERE DO WE GO FROM PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY063303039 90000'817000'11d OJ. HOIHM SBNIHVEJEI (ENEDISEICI as SSNIHVEIEI as Jr HEHLO NOI SLNEIINEIONVHNEI. aowuns CINOINVICI aowans OIWVHEIO as NO as swmaww axn El'lanO BNIHVEIEI 'l II. CURRENT ISSUES A.) METAL 0N METAL HIGH VOLUME PARTICLE GENERATION METAL ION RELEASE OPTIMAL GAP TOLERANCES - POOR WEAR RESULTS (LEEDS TESTING) METAL SCRATCHES HAVE PEAKS AND VALLEYS B.) CERAMIC 0N CERAMIC ALUMINA VS. ALUMINA ZIRCONIA VS. (POOR WEAR COUPLE) CATASTROPHIC FAILURE DUE TO IMPROPER COMPONENT DESIGN I (RIM FRAGMENTATION) ORIENTATION OF COMPONENTS LOWER VOLUME PARTICLE GENERATION. MATERIAL ALL READY OXIDIZED CERAMIC SCRATCHES HAVE VALLEYS ONLY IMPROVED WEAR RESISTANCE PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY063303041 0.) SURFACE DIAMOND - GREAT HARDNESS 1/2 - 3/4 HARDNESS OF DIAMOND - DIFFICULTY PRODUCING SPHERICAL SHAPES DUE TO THERMAL EXPANSION - Ti NITRIDE -ADHESION PROBLEM - FLAKES - DEFECTS CAN LEAD TO FRACTURES AND COATING VOIDS - D.) SURFACE ENHANCEMENTS ION BOMBARDMENT - EXTREMELY THIN LAYER (.05um) - WEAR ADVANTAGE SEEN ONLY DURING FIRST 1/2 MILLION CYCLES PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY063303042 60000'817000'11d OJ. CINV EISVEI AVW AVW 'sassaoaa HO SEAOOHB HEHLO OJ. J.V HCI 8 NEIN EISEIHL EWOOHEIAO EIM NVO MOH A TELL AHOLSIH SEIOCI .LVHM Elam??Vi IV. WHERE DO WE GO FROM 1 ALL OPTIONS THE ENVELOPE OF TECHNOLOGY (BOTH DESIGN AND MFG) AT OTHER INDUSTRIES OUTSIDE THE ORTHOPEDIO ARENA IDEASII (I.E..BEARING COM PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY063303045