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Biomet M2a Magnum Hip Implant

Serious Complications Associated With Biomet M2a-Magnum Hip Implant

The Biomet M2a-Magnum Hip Implant, an all-metal hip implant, was approved by the FDA in 2004. Like many other metal-on-metal hip implant components, the Biomet M2a-Magnum was designed to last 15 years or more. Unfortunately, many patients implanted with these devices have reported early device failure and other serious complications. By 2012, more than 300 Biomet M2a-Magnum hip implant lawsuits had been filed.

Complications resulting from metallosis caused by the Biomet metal-on-metal implants are similar to those which prompted recalls on similar devices- DePuy ASR and Zimmer Durom hip replacement systems.

BIOMET HIP IMPLANT COMPLICATIONS AND INJURIES

In affected patients, the metal components of their hip implant rub together, releasing tiny metal particles into the blood stream, soft tissue, and internal organs. This can lead to metallosis, or metal poisoning, which may cause:

  • Swelling
  • Severe joint pain
  • Tissue damage at implant site
  • Tissue necrosis/death
  • Loosening of the implant
  • Hip dislocation
  • Hip fracture
  • Need for revision surgery

BIOMET HIP IMPLANT RECEIVED 510 (K) FAST TRACK APPROVAL

The Biomet M2a-Magnum hip implant was approved under the U.S. Food and Drug Association’s 510(k) pre-market notification program which “requires demonstration of substantial equivalence to another legally U.S. marketed device” (FDA). Under the 510 (k) approval process, in order to receive market clearance, manufacturers need only show their product is similar to another device which has already been tested and cleared for the market.

In accordance with the so-called “fast track approval,” the manufacturer was not obligated to conduct clinical trials or perform any other kind of pre-market testing before the Biomet M2a-Magnum Hip Replacement was used on patients.

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