Parker Waichman Representing NY Man in Biomet Metal-on-Metal Hip Implant LawsuitJun 6, 2012 | Parker Waichman LLP
The national law firm, Parker Waichman LLP, just filed a lawsuit alleging that the Biomet M2a Magnum metal-on-metal hip implant caused pain and the need for revision surgery in their most recent client, in a New York man. This is one of a growing number of cases concerning controversial all-metal hip replacement devices that Parker Waichman, LLP has filed.
This lawsuit, which was filed on May 30, 2012 in the U.S. District Court for the Southern District of New York, names Biomet Inc., Biomet LLC, and Biomet Orthopedics as Defendants (Case No. 12-cv-4342).
The New York alleges that he was implanted with the Biomet M2a Magum hip replacement last February and that the device’s defective design caused him severe pain and led to implant failure. One year after his implant surgery, the man had to undergo a revision surgery to remove the device. The lawsuit also claims that Biomet sold, and continues to sell, the implant despite the lack of adequate testing and Biomet’s knowledge of these defects. According the complaint, over 350 adverse event reports linked to the Biomet hip replacement have been filed with the U.S. Food and Drug Administration (FDA).
Parker Waichman LLP describes the Biomet M2a Magnum as a metal-on-metal hip implant that utilizes a metal ball, or head, that is fitted on top of a femoral stem and that works in collaboration with a metal socket, or cup. Metal-on-metal devices, notes Parker Waichman, LLP, are controversial over reported complications such as high failure rates; necrosis (tissue death); increased cobalt and chromium ion levels; pain at the implant, sometimes spreading to the groin and back; osteolysis (bone loss); and fluid collection/solid masses near the hip joint.
Parker Waichman, LLP points out that an ever-growing body of research questions the safety of metal-on-metal hip implants. For instance, in February, the British Medical Journal (BMJ) warned that all-metal hip recipients may have been exposed to dangerously high levels of metallic debris. In March, the Lancet published a study revealing that metal-on-metal implants fail at a rate of 6% in five years, as opposed to the 1.7 - 2.3% seen in prior plastic or ceramic versions; those findings prompted the authors to recommend against using the devices altogether. Last month, a study in the Journal of Arthroplasty linked corrosion of the head-taper junction in metal hip replacements to adverse local tissue reaction. Most recently, a study in the Journal of Bone & Joint Surgery found that 39% of patients with all-metal implants developed pseudotumors, a risk that significantly increased with elevated metal ion levels.
The U.S. Food and Drug Administration (FDA) has asked 21 manufacturers to conduct post-market studies to determine the impact of metallic debris in all-metal hip implant recipients. On June 27th and 28th, the agency’s Orthopaedic and Rehabilitation Devices Panel will weigh the risks and benefits of the devices.
The most commonly reported defects and injuries associated with the Biomet M2a Magum hip replacement are its high failure rate and the need to be replaced long before a prospective recipient is told it would need to be replaced. All-metal implants like this Biomet device are marketed toward younger recipients because they’re supposed to last longer than traditional implants. The opposite has been true across nearly the entire market; nearly every metal-on-metal implant features a high early failure rate.