Since 2009, there has been a significant increase in adverse reports to the FDA involving the Biomet M2A Magnum hip replacement system. In 2009, the FDA received only eleven reports of adverse events associated with this device. The agency received eighty reports in 2011.
Adverse events included reports of acetabular cup loosening, metallosis, bone loss, chronic pain, popping or squeaking, metal poisoning and pseudutumors. Because adverse events are underreported to the FDA, it is likely that the number of people harmed by this device is substantially greater. |
