Smith & Nephew Recalls Metal Hip Implant Part

After experiencing dissatisfying clinical results with the optional metal liner component in the R3 Acetabular system, Smith & Nephew has decided to take the part off the market. However, the part, which serves as the “socket” portion of a hip implant, has already been implanted in about 7,700 patients since becoming available in 2007. Such action was based on clinical data from multiple sources, including the U.K. National Joint Registry and the Australian National Joint Replacement Registry, which showed revision rates of 6.3% after four years for the part and 4.96% after two years, respectively. This is not the first time issues with the R3 system have arisen. In December of 2010, the FDA issued Smith & Nephew a warning, claiming that the company hadn’t performed adequate tests of the product and that it failed to establish and maintain a process that would correct manufacturing problems. Subsequent to the U.K. – based company’s decision to engage in what it terms as “voluntary market withdrawal” of the optional part, S & N stock has fallen sharply, resulting in a 3% drop in early trading. Injury from metal hip implants has led to metal hip implant recalls by Smith & Nephew and DePuy, and metal hip implant lawsuits against Smith & Nephew and DePuy.

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