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JOHNSON & WARD FILES SUIT AGAINST SMITH & NEPHEW IN KNEE RECALL CASE
Clark H. McGehee and William C. Lanham, partners at Johnson & Ward, an Atlanta based law firm, have filed suit on behalf of an Atlanta, Georgia, resident against Smith & Nephew, Inc., a global medical devices company with U.S. headquarters in Memphis, Tennessee, for injuries resulting from the failure of a total knee implant system, manufactured and marketed by Smith & Nephew.
The Complaint was filed on January 29, 2004, in the State Court of Fulton County, Atlanta Division, alleging that defects in the Smith & Nephew knee implant resulted in significant injuries to the claimant.
Smith & Nephew recalled two types of its knee implants in September of 2003, the cementless macrotextured versions of its Oxinium Genesis II and Profix II implants, after a number of these implants failed to properly bond to patients' bones after total knee replacement, resulting in an excessive failure rate. When the defective knee implant fails, it causes loosening in the knee joint, with accompanying pain and swelling, which may result in the necessity of a second revision surgery to replace the defective implant. These patients face painful rehabilitation, additional surgical and medical expenses, additional lost time from work, increased disability, increased risk of re-infection, and additional joint and muscular damage due to additional scar tissue.
Smith & Nephew announced the introduction of the cementless macrotextured Profix II and Genesis II total knee systems, utilizing oxidized zirconium material, in a press release dated June 18, 2002, indicating that the "macrotextured femoral component features a roughened, three dimensional contour to the fixation surface of the implant... with a mean pore size of 350 microns... an integral part of the base metal." The report further indicated that Smith & Nephew's oxidized zirconium knee systems had "dramatically boosted knee sales in the past year," and that the new oxinium macrotextured knee systems would be widely marketed and sold commencing in the Fall of 2002. (Read the complete article).
Smith & Nephew, in a subsequent article published in the September 18, 2003 edition of "The Guardian (UK)," reported it had stopped sales of the cementless macrotextured versions of these two knee replacement systems because of the higher than expected number of follow-up operations. According to this news report, a Smith & Nephew spokesman stated that about 30 of the 3,000 patients fitted with the cementless versions of its Oxinium Genesis II and Profix II implants in the United States required surgical revision after the implants became loose, and that this is "higher than Smith & Nephew would normally see." This spokesman also reported that Smith & Nephew had alerted U.S. authorities after the problem first came to light in August, and withdrew these products voluntarily for reasons of patient safety, until it could determine what was causing the problem. (Read the complete article).
Reported failure rates for the Smith & Nephew Genesis/Genesis II and Profix/Profix II knee replacement systems, as shown in the U.S. Food & Drug Administration Medical Device Adverse Event Reporting Data Files, are much higher than those noted by Smith & Nephew, however. These reports reflect increasing failure rates throughout 2003 for both the Genesis II and the Profix II systems. In fact, as reflected in the FDA's Manufacturer User Facility and Distribution Experience (MAUDE) Database, there have been 162 reported adverse events or failures pertaining to the Genesis/Genesis II system, and 81 adverse events or failures concerning the Profix/Profix II system, through December 30, 2003. (Visit www.fda.gov).
Attorneys at Johnson & Ward will continue to investigate the cause of these failures, and inquire into the research and testing that went into the development of the macrotextured cementless knee implant system. They will also continue to review failures occurring throughout the country, and monitor other cases filed against Smith & Nephew arising out of failures of these knee implant systems, in an effort to determine if Smith & Nephew timely responded to the numerous reported failures of its implants, and whether it properly sold this new cementless knee implant system with adequate pre-market research and testing.