A patient and his wife have filed a lawsuit against Biomet Orthopeadics claiming that the M2a Magnum hip implant is defective and dangerous in its design.

Plaintiffs Larry and Janis P. say that Larry had his right hip replaced with the Biomet M2a Magnum hip implant on or around Nov. 28, 2005 in Florida. He says that the device’s metal-on-metal design is defective in such a way that caused him severe physical injury. Larry alleges the complications were so severe that he had to undergo revision surgery to remedy the injury and replace the Biomet M2a Magnum hip with a different device.

He says that the metal-on-metal design functioned incorrectly in his body, causing the device to shed metal particles into his body. This leads the device to not allow proper movement, resulting in pain and an infection, according to the Biomet lawsuit.

Larry says that the revision surgery required to remedy his injuries was risky in itself and caused him further medical expenses and pain and suffering. He claims that even after the revision surgery, his right hip, with the second implant, continues to be weaker than his left hip.

Larry and Janis aim to hold Biomet accountable for Larry’s physical, emotional, and financial injury they claim was caused as a direct result of the device. They claim that Biomet knew or should have known that the device was defective, but marketed it as safe and effective. Larry says that he had no way of knowing that the Biomet M2a Magnum hip implant would cause him injury, and had to rely on the advertisement of the device, and on his surgeon’s advice. Allegedly, Biomet misrepresented the device to medical professionals, the FDA, and to patients.

Larry says that had he known that the Biomet M2a Magnum hip implant device was dangerous and defective, and had he been given accurate information about the device, he would have chosen to have a different hip implant used during his hip replacement surgery.

The couple says that after Larry’s initial hip replacement surgery, he developed a superficial MRSA wound infection, which was resolved after taking antibiotics four around two months. He says that he then suffered severe pain in his right hip, and then saw an orthopedic surgeon after the pain had gone on for about a week. Allegedly, he was prescribed Flexetril, a muscle relaxant, and was given exercises to perform. He was then told to return in a year for a metal test.

Allegedly, when he returned for metal tests a year later, the levels of cobalt and chromium were elevated, because the cobalt and chromium in the Magnum M2a had fretted into the surrounding tissue.

The Biomet M2a Magnum hip implant lawsuit says that Biomet did not sufficiently test the device before releasing it onto the market. Allegedly, the device was approved through a “fast track” approval process that allows medical devices to be released onto the market with limited pre-market testing if they are “substantially equivalent” to a device already on the market.

However, the Biomet lawsuit says that the device’s approval was based in showing that it was similar to three hip replacement devices that had a metal-on-polymer, not a metal-on-metal design, so the risks of a metal-on-metal device were not sufficiently examined before the device was released onto the market.

The Biomet M2a Magnum Hip Implant Lawsuit is Case No. USDC IN/ND Case No. 3:18-cv-00635-RLM-MGG, in the U.S. District Court for the Northern District of Indiana, South Bend Division.