Borri Law Offices is investigating hip replacement failures involving the Biomet® M2a-Magnum™ hip implant system. The Biomet® M2a-Magnum™ hip replacement system consists of a metal cup made of a cobalt chromium alloy and is frequently paired with a large diameter Biomet® cobalt chromium modular head. So-called metal-on-metal total hip replacements have been associated with adverse effects such as metallosis, pseudotumors, tissue death (necrosis), bone loss (osteolysis), and metal blood poisoning.
Reports to the FDA of Biomet® M2a-Magnum™ Hip Replacement Failures Skyrocket
Over the past two years the annual number of adverse events involving the Biomet® M2a-Magnum™ hip replacement reported to the United States Food and Drug Administration has increased by 800%, rising from eleven in 2009 to eighty in 2011. Adverse event reports submitted in 2010 and 2011 have included events of acetabular cup loosening, metallosis, chronic pain, bone loss (osteolysis), popping or squeaking noises, effusions (liquid around the hip joint), pseudotumors, and metal poisoning.
Joint Registry Data Shows Rising Surgical Revision Rates for Biomet® M2a-Magnum™ Metal Hip Implant
The 2011 Report of the Australian National Joint Registry, which tracks surgical revisions of orthopaedic devices in Australia (the United States does not have a registry that tracks the performance of orthopaedic medical devices), showed that the Biomet® M2a-Magnum™, paired with a large diameter Biomet® M2a cobalt chromium metal head had a yearly cumulative revision rate of 7.2% (95% confidence interval) after seven years, with a statistical range between 5.3% and 9.7%. This is a much higher revision rate than some other metal-on-metal hip replacements. For instance, the Ultamet metal insert paired with the S-Rom stem and large diameter metal head showed a cumulative annual revision rate of only 3.7% after 7 years.
Just as importantly, metal-on-metal hip replacements as a class are being revealed to be worse or, at best, no better than traditional metal on polyethylene hip replacements, but associated with greater risks. Although aggressively marked by implant manufacturers as long lasting and suitable for younger, active patients, many of these metal-on-metal implants were not tested in humans before they were marketed to the public. Now, Dr. Thomas Schmalzried, one of the designers of the DePuy ASR XL hip replacement system has concluded that the risks associated with the metal-on-metal total hip implants outweigh their benefits. See Schmalzried T. Metal-Metal Articlulation: Is it Worth the Risk?, presented at the 17th Annual Meeting of the Hip Society and the AAHKS, February 19, 2011.
Furthermore, a recent comprehensive study published in the British Medical Journal did not find any advantage for metal-on-metal hip replacements and reported evidence from the three largest national joint registries found higher rates of implant revision associated with metal-on-metal implants compared with traditional metal on polyethelyne implants. Sedrakyan A., et al. Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence. British Medical Journal 2011;343:d7434.
Contact Borri Law Offices for a Free Consultation on a Biomet® Hip Replacement Lawsuit
If you are one of the more that 500,000 people implanted with a metal-on-metal hip replacement and are experiencing or diagnosed with:
- the need for revision surgery (a second surgery to replace your hip implant);
- groin pain, hip pain or inflammation;
- clicking, popping, grinding, or squeaking noises emanating from your hip;
- partial or complete dislocations of your hip replacement;
- elevated blood metal levels of cobalt or chromium;
- effusions (liquid around the hip joint);
- osteolysis (bone loss); or a
- lose cup or femoral stem
Contact us for a free consultation and learn whether you have grounds for hip replacement lawsuit.