PINELLAS PARK, Fla.--(federal lawsuit against Biomet Orthopedics, LLC and Biomet Inc. regarding alleged an defective metal on metal Biomet M2-a Magnum hip system implanted into Darryl Richards. While the Biomet M2-a Magnum hip system has not been recalled, there have been numerous adverse event reports associated with this hip system. According to Attorney Joseph Saunders, the problems associated with this hip system involve similar design defects and failures associated with other failed hip replacement implant systems that have been recalled. This includes the release of the metal cobalt and chromium ions. Saunders claims that in this particular case, the surgeon performing the revision found metal staining on the tissue inside the hip from the metal from the Biomet magnum implant that had to be removed.)--Attorney Joseph H. Saunders of nationwide law firm Saunders & Walker P.A. has filed a
Research has shown that the metal on metal hip replacement implants have a higher than normal failure rate and secrete metal particles into the bloodstream. This condition is known as metallosis.
The Biomet M2-a Magnum hip system is not the only metal on metal hip replacement implant device that has experienced higher than acceptable failure rates. According to Attorney Saunders, hip replacement implant systems such as the DePuy ASR XL, the DePuy Pinnacle, and the Wright ProFemur Total Hip System, have all experienced design defects that may cause those who received them pain and suffering. Each of the above named hip replacement systems are the subject of medical device lawsuits.
The metal-on-metal M2-a hip system is considered by the FDA to be a Class III device, meaning it operates to sustain life, is of substantial importance in preventing impairment of human life, or it poses potentially unreasonable risks of harm to humans. This last definition is important because this particular hip system, the Biomet M2-a Magnum, is the subject of this lawsuit and has been classified Class III by the FDA. When it was introduced to the marketplace, it was “grandfathered” and therefore allowed to bypass the rigorous testing process required by other medical devices. The reason for this exception concerns the hip system’s classification as being a device that is substantially similar to other, pre-approved medical devices, which is the requirement for devices classified as Class II. In the lawsuit, it is alleged that Biomet knew or should have known that its M2-a Magnum hip system could lead to metallosis and other health complications. However, the company allegedly failed to subject the system to further testing and clearance prior to marketing the device. As early as 1996, (the M2-a Magnum hip system was approved in 2004) Dr. Jonathan Black, Ph.D., warned in a medical journal article that such metal-on-metal hip devices posed significant risks to potential patients because too little was known at the time concerning the effects of metallic debris which might be caused by the design of these hip replacement implants.
The Biomet M2-a Magnum hip replacement system, in similarity to those manufactured by DePuy and Wright Medical Technology, were marketed as superior hip devices without scientific support of such claims. Furthermore, the known risks of these new devices far outweighed the stated or proven benefits to patients.