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Biomet Metal-On-Metal Hip Implant Alleges Injuries Led to Risky Revision Surgery

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Another Biomet metal-on-metal hip recipient says her implanted hip caused her to undergo risky revision surgery. Twice. The national law firm, Parker Waichman LLP, filed a lawsuit on behalf of the woman who was implanted with the Biomet M2a Magnum Hip System. Biomet. Inc., Biomet, LLC, and Biomet Orthopedics, LLC have been named as defendants.

This Biomet metal-on-metal implant has been associated with a high rate of early failure and, according to the lawsuit, the Biomet implant failed twice in this woman, forcing her to undergo two revision surgeries.

According to the complaint, the woman was implanted with the Biomet M2a Magnum Hip System on her left hip in December 2005. That implant failed and she was forced to undergo revision surgery to replace the original device with a new M2a Magnum Hip System. The replacement also failed, and the patient had to undergo a second revision surgery.

Revision surgery is performed when complications associated with a hip implant become unbearable or pose unreasonable risks. According to the lawsuit, this procedure is more complex and risky; revision surgeries typically take longer than initial implantation and are associated with a higher rate of complications. In light of the fact that the woman underwent two revision surgeries on her left hip, the lawsuit alleges that she has been exposed to much greater risks. The lawsuit also alleges that the device caused the woman to suffer from economic damages—lost wages and medical expenses—severe and potentially permanent injuries, pain, suffering, and emotional distress.

The lawsuit explained that the Biomet M2a Magnum hip system uses a “monoblock” system that prevents the patient from being able to use any type of acetabular liner. As a result, the device’s metal surfaces rub together with the full weight of the body.

The lawsuit alleges that this metal-on-metal design is defective, and causes an excessive amount of cobalt and chromium ions to corrode from the implant; these particles can cause the body to react negatively, and result in pain, looseness, dislocation, squeaking and popping sounds, fluid build-up, and necrosis of bone and soft tissue.

The lawsuit states that, at the time the woman received her first implant, there were already over 100 adverse event reports associated with the M2a Magnum. The lawsuit also alleges that the defendants hid this information from the patient, her orthopedic surgeon, and the public and that the surgeon would not have used the hip system if the defendants had not made misleading statements about its safety and efficacy.

Metal-on-metal hips, which gained notoriety after the DePuy recall in August 2010, are associated with a high rate of early failure. In March, the Lancet published a study showing that all-metal hips fail at a rate of six percent in five years, whereas metal-on-ceramic or metal-on-plastic implants fail at a rate of approximately two percent. Last month, a study published in the journal, Orthopedics, investigated patients with failed metal hips and found that 92 percent of the revisions were performed within three years.

The U.S. Food and Drug Administration (FDA) has asked a number of manufacturers to conduct post-market safety studies of metal-on-metal hips, hoping that the research will provide insight as to whether the devices release toxic amounts of metal ions into patients’ bodies. In June, the agency also convened an independent expert advisory panel to weigh the risks and benefits of the devices. Overall, the panelists agreed that there is little reason to use metal-on-metal hips in the future.

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