A California man has filed a lawsuit alleging that his Biomet 38mm-M2a metal-on-metal hip replacement system is defective and caused pain and injuries, including elevated cobalt levels. The suit claims that he may need revision surgery to remove and replace the hip.
The plaintiff had a Biomet 38mm-M2a ball and socket hip with a Bi-Metric Porous Stem implanted in his right hip. The lawsuit alleges that by the time of this implant surgery, the defendants were aware of over 100 adverse event reports linked to the device, yet they failed to disclose this information to the plaintiff, instead misrepresenting the implant as safe and effective.
The lawsuit alleges that, as a result of the Biomet M2a’s defective design, the plaintiff’s hip replacement failed shortly after it was implanted, resulting in severe pain. In September 2011, he was found to have elevated cobalt levels, and it is likely that he will need to undergo complex, risky revision surgery to remove and replace the device. Revision surgeries, the complaint explains, are generally more complex than initial implantation because there is typically less bone to work with than in the original surgery. Revision surgeries usually take longer than the original implantation; have a higher rate of complications; and longer recovery time.
Metal-on-metal hip devices have been recalled worldwide, the U.S. Food and Drug Administration (FDA) notes. These devices are under FDA scrutiny following reports of high failure rates and the release of elevated concentrations of metallic debris into the bloodstream. In January the FDA released new guidelines for patients with all-metal devices. The agency advises regular physical examinations, diagnostic imaging, and metal ion testing for symptomatic patients.
Parker Waichman LLP filed the lawsuit on Sept. 13, 2013 in the U.S. District Court for the Northern District of Indiana, South Bend Division (Case No. 3:13-cv-951). It is one of many cases pending in the multidistrict litigation (MDL) entitled In re: Biomet M2a Magnum Hip Implants Products Liability Litigation (MDL No. 3:12-md-2391).