The Biomet M2a- magnum hip implant was introduced to the market in 2005. It was marketed for active and younger patients. The Biomet M2a-magnum has three metal components, including a metal femoral head, a metal insert and a metal acetabulum cup. Metal-on-metal hip implants have been shown to cause a wide variety of adverse effects including the release or metal ions and debris, cup loosening and high failure rates. The Biomet M2a hip implant is no exception. There have been reports of patients experiencing loosening, metal ion debris, wear or failure of the device since its introduction on the market. Notably, the metal-on-metal hip implant components have been touted as lasting for 15-20 years but data from the FDA has shown that they have much lower success rates than what has been marketed.

As the concerns regarding metal-on-metal hip implants continues to mount, as the FDA has requested hip implant manufactured to report data related to the metal ion levels in blood of implant patients and the potential harmful effects associated with elevated metal ion levels.

Despite these concerns, Biomet claims that their M2a-Magnum metal-on-metal hip implant provides wear reduction, specifically, a “99% reduction in wear” and its large heads allow greater movement and stability. The FDA has received numerous adverse event reports related to the Biomet M2a-Magnum hip implant found here, here, here and here. The common thread amongst these adverse event reports is that each of the patients had to undergo a revision of their Biomet M2a-Magnum hip implant. Biomet’s assertions that their metal-on-metal hip implant is safe are deceptive.

Some of the common side effects and complications that might arise from having a Biomet M2a Magnum metal-on-metal hip implant include:

• Increased levels of metal ions
• Increased metal wear rates which may cause metal debris
• Loosening of the hip implant
• Osteolysis
• Necrosis – death of the tissue surrounding the implant
• Severe hip pain due to dislocation or metal wear
• Revision surgery – surgery to remove the failed metal-on-metal hip implant
• Pseudotumors

A study published in the Lancet in March 2012 revealed that metal-on-metal hip implants fail at very high rates. Specifically, the study found that a failure of the device is related to head size with larger heads failing earlier. Clearly, Biomet’s promise that its large heads will allow greater movement and stability is not supported by the literature. The 5 year revision rates were 6% for metal-on-metal hip components compared to 1.6% for metal-on-polyethylene and 3.3% for ceramic-on-ceramic. The ultimate findings of the study were that metal-on-metal implants have poor survival rates and should not be implanted. Patients who already have metal-on-metal hip implants should be very carefully monitored.

Even more recently, in July 2012, a study was published in Orthopedics Journal that found a 95% of patients with metal-on-metal hip implants that failed need to have a revision surgery within three years of the implant failing.