Biomet M2A Magnum Hip Implant: FDA Stance

Few hip replacement surgeries were performed on those younger than sixty in the past under the belief that older patients were less active therefore would place less stress and strain on an artificial hip joint. Hip implants were initially constructed of polyethylene or ceramic, however manufacturers began constructing the implants out of cobalt and chromium under the belief they would hold up much longer than the polyethylene or ceramic implants. The past ten years have seen more physicians considering hip replacement surgery in younger patients, particularly those who suffer from such diseases as rheumatoid arthritis or those who have undergone bone tumors, fractures or serious hip injuries. The goal of hip replacement surgery is to provide a lessening of pain, a quality-of-life improvement and increased range of motion.

The FDA Approval of the Biomet M2A Magnum

The Biomet M2A Magnum all-metal hip implant received FDA approval under the controversial 510(k) process in 2004. Complaints for the M2A Magnum (and all metal-on-metal hip implants) began surfacing soon after they began being routinely implanted in patients—sometime in 2006. Zimmer, Inc. recalled their all-metal hip implant in 2008, and two years later DePuy recalled their ASR all-metal hip implant systems. Just this year Stryker recalled its Rejuvenate and ABGII metal—on-metal hip implants.

Most of the adverse reports received by the FDA eventually resulted in early device failures which led to expensive and potentially dangerous revision surgery. In fact, revision surgeries for all-metal hip implants totaled over 14,000. Although the all-metal hip implants were believed to have a life expectancy of fifteen or more years, the estimates—depending on the specific device—range from 7.5% to as high as 50% failure rate. The FDA can only order a Post-Market study of these all-metal hip implants for three years, meaning devices which last slightly longer than three years will not be reported as being ineffective or having failed.

If You Have Experienced Difficulties with Your Biomet M2A Magnum

Even if you have not yet experienced difficulties with your Biomet M2A Magnum implant you could well find yourself having problems later on. Those recipients of the M2A who have failed to consult an attorney and join in the litigation against Biomet may find they are in a difficult financial and medical position. Each recipient of the Biomet M2A Magnum should have a thorough understanding of the potential risks and symptoms of failure. Many elderly patients may actually be suffering chronic and severe pain, inflammation and difficulty with mobility yet are unaware of the potential risks of the M2A so chalk their symptoms up to advanced age. Although the FDA has not yet mandated a recall of the Biomet M2A Magnum, recipients of the device should consult their physician as well as an experienced attorney who can offer solid information regarding the dangers of the Biomet M2A Magnum.

Call the highly experienced attorneys of Sullo & Sullo today and get the information you need in order to make an informed decision about pursuing a claim.


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