Plaintiff Carol M., a resident of Hays County, Texas, is suing Biomet Inc. for the injuries she allegedly sustained using the company’s metal hip implant, the M2a Magnum Hip System.

Carol underwent surgery in 2004 to have the M2a Magnum Hip System implanted. Shortly afterwards, she began to experience extreme hip, leg, and back pain. As a result of the allegedly defective hip implant device, Carol has sustained tissue damage, necrosis, and an accumulation of metallic debris in her blood. In 2014, Carol underwent revision surgery to remove the hip implant.

The M2a Magnum Hip System, and other similar metal-on-metal hip implant systems, was developed in order to effectively reconstruct human hip joints. These joints may need implants because of conditions such as osteoarthritis, rheumatoid arthritis, avascular necrosis, and/or fracture.

While most hip implants have metal balls fixed on top of a femoral stem implanted on the femur and then placed inside a liner and an acetabular shell, the M2a Magnum Hip System’s design places the metal ball directly in contact with another metal piece, the metal acetabular shell. This design was never approved by the Food and Drug Administration (FDA) as safe or effective, and Carol’s metal hip implant lawsuit claims that the system was insufficiently tested by the defendants.

Carol claims that Biomet had material knowledge that its metal-on-metal hip systems, including the M2a Magnum Hip System, were defective and therefore not safe, contrary to their promotion of the product. The M2a’s predecessor, the M2A 38, reportedly caused adverse events such as premature failure, dislocation, fracture, and inflammation to the surrounding tissues.

The M2a Magnum Hip System was approved through the 510(k) process, which avoided expensive clinical trials and an FDA review. Since that approval, over 350 adverse events have been reported to the FDA regarding the M2a Magnum Hip System.

Reported Problems With Metal-On-Metal Hip Implants

The British Medical Journal published a study by the FDA covering over five years of clinical trials and observational studies that determined there was no greater efficacy in metal-on-metal implants than those with a polyethylene liner. Further, the study showed that metal-on-metal implant systems, including the M2a Magnum Hip System, significantly increased the risk of revision surgery for its users.

The Australian Orthopedic Association and the British Medicines and Healthcare Products Regulatory Agency have both recognized for several years the problems associated with metal-on-metal implants such as the M2a Magnum Hip System.

Despite these studies and reports, Biomet continued to market their hip implant system as safe and effective. In fact, Biomet marketed the product as providing a “greater resistance to dislocation and improved implant stability,” though reports and studies have indicated the opposite to be true.

Carol’s hip implant lawsuit asserts that Biomet had a duty to inform consumers of potential risks prior to implant surgery, and update their warnings regarding the risks following the release of reports and studies that showed considerable risk. Carol further alleges that, because Biomet had knowledge of its product’s defectiveness yet continued to market it as safe and effective, Biomet intentionally suppressed and concealed both the risks of their product and the fact that safer alternatives were available.

If you have experienced complications due to a metal-on-metal hip implant from Biomet or another company, you may be able to file a metal hip implant lawsuit.

The Biomet Metal Hip Lawsuit is Case No. 3.15-cv-00296-RLM-CAN, in the U.S. District Court for the Northern District of Indiana, South Bend Division.