Zimmer NexGen Replacement System Defect InfographicCompanies who fail to put the requisite time and research into their product before placing it on the market often must face the consequences of their inadequate preliminary processes. Companies typically might say that they performed all of the necessary research as mandated by the U.S. Food and Drug Administration (FDA) before placing their product on the market, and thus, that liability should not be put on them.

If large companies are let off the hook for their failure to conduct adequate investigations into whether certain products manufactured by them are safe who, then, will bear the costs of such company shortcomings? Surely it should not be the innocent consumers and patients who rely on both the word of their presumably knowledgeable physicians, and the products with which those physicians supply them.

Large manufacturing companies cannot plausibly argue that consumers should have to perform an independent thorough investigation before utilizing a company’s product. If the manufacturing companies asserted this, it would be akin to saying that under no circumstance should patients rely on the superior expertise of the physician who supplies them with the product. Additionally, if consumers had an independent obligation to perform extensive research into a product’s safety, no longer could consumers place reliance on the manufacturer- the party in the best position to assess the product’s risks and dangers. Moreover, placing such a heavy research burden on consumers likely would deter consumers from purchasing and/or utilizing a particular product and thus, it is not probable that manufacturers would even contend that the ultimate responsibility of product safety lies with consumers.

Recently, the Indiana-based global medicine device company Zimmer, Inc. was criticized for placing a faulty product, the NexGen knee replacement system, on the market. Additionally, Zimmer, Inc. has been accused of failing to adequately warn consumers of some of the risks of its products.

Zimmer NexGen Replacement knee deviceThe Zimmer NexGen knee replacement implant has been identified as posing the risk of various complications to users of the product including, among other problems, an extremely high failure rate, loosening, and pain. The high failure rate of the Zimmer NexGen knee implants likely is due to design problems of the product.

Following a review of research conducted on the Zimmer NexGen knee replacement implant, failure rates of the product in patients examined after two years were reported to reach an unacceptably high 9%. Additionally, users of the product also reported experiencing pain and/or loosening of the knee replacement implant; 36% of patients examined after two years showed signs of the Zimmer NexGen knee replacement implant loosening.

The problems associated with the product likely stem from the “high-flex” porous femoral component of the product, which, unlike most knee replacement implants, does not use surgical cement to keep it in position. Such an absence of surgical cement may increase the risk of the “high-flex” porous femoral component loosening, which often requires surgical correction. Several knee replacement recipients have been required to undergo additional revision surgeries to correct problems and complications associated with the defective product.

Surely, manufacturers who place a faulty product on the market without first adequately assessing that product’s risks and dangers should bear the cost of any negative consequences arising from that product. And, as they have traditionally been able to, consumers and patients should continue to be able to rely on the representations of manufacturing companies regarding the effectiveness and safety of their products, and on the physicians who recommend those products. Manufacturing companies and the FDA need to ensure that consumer safety is among their organizations’ highest priorities by taking responsibility and corrective measures when consumer safety is jeopardized.