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Lawsuits Claim Zimmer NexGen LPS Knee is Defective

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Late last month, three lawsuits were filed against Zimmer Inc., a medical device company, alleging problems with the company’s knee implant system, the Zimmer NexGen Legacy Posterior Stabilized (LPS). Knee implant recipients claim to require revision surgery shortly after replacement surgery due to the device becoming loose or failing. The Zimmer NexGen LPS system utilizes a “high-flex” component that allows a greater degree of flexion than the standard femoral component. The three plaintiffs allege the device maker portrayed Zimmer NexGen LPS system as safe, but had

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prior knowledge of serious injuries associated with the high-flex component. Plaintiffs contend that the component’s degree of flexion creates a high risk of loosening, which causes higher-than-expected failure rate, eventually leading to early revision surgery. In 2007, The Journal of Bone and Joint Surgery (British Edition) published a study detailing that 38 percent of Zimmer NexGen LPS implant recipients reported loosening two years post knee implantation surgery. Subsequently, more than half of the recipients required revision surgery due to the device failing. In September 2010, a recall of some non-conforming Zimmer NexGen LPS high-flex components with inconsistent geometry was issued by the company. According to the U.S. Food and Drug Administration (FDA), the recall occurred because “the implant surface may not have been polished adequately, which could result in increased wear and plastic debris generation”. The FDA’s actions took place shortly after Zimmer issued a recall of Zimmer NexGen MIS. The nearly unnoticed recall included more than 68,000 implant parts, specifically 158 flex gender femoral components and 192 femoral components of various sizes were affected. Zimmer is not unfamiliar with allegations of defective knee replacement devices. In March 2010, Dr. Richard A. Berger, a former Zimmer consultant, presented data on 108 patients who received the Zimmer NexGen CR-Flex Porous Femoral Component, stating that nine percent of thosecases examined required revision surgery. The CR-Flex components cited by Dr. Bergers study was not included in the September 2010 NexGen LPS recall even though loosening of the implant occurred in more than a third of cases he reviewed. Zimmer dismissed Dr. Berger’s concerns and suggested that his surgical skills were at issue and not the device design. The company continues to stand by its claim that the product is “the most trusted knee system in the world”.

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