The Biomet M2a hip replacement is the subject of a new lawsuit filed in the U.S. District Court for the Northern District of Indiana, South Bend Division. The plaintiff, Kenneth K., is a citizen and resident of the state of Pennsylvania.

Kenneth filed the legal claim against Biomet Inc. and related subsidiaries, John Cuckler, M.D., and Alabama Medical Consultants on June 20, 2018, due to allegations that the Biomet M2a hip replacement system is defective.

The Plaintiff’s Experience with the Biomet M2a Hip Replacement

According to the narrative of Kenneth K.’s lawsuit, he engaged the services of orthopedic surgeon Vincent Ripepi, D.O. for an evaluation of chronic pain occurring in his right hip.

Upon investigation, Dr. Ripepi allegedly determined that Kenneth would best be served by implanting him with a metal-on-metal Biomet M2a hip replacement prosthetic for better joint function. The surgery took place on Jan. 12, 2010.

Kenneth says the Biomet M2a hip replacement choice was made based upon the surgeon’s feeling that it would most closely function like the plaintiff’s natural hip. Initially, he says, there were no problems associated with the new hip prosthetic unit.

Gradually, however, Kenneth says he began to experience chronic pain and inflammation on that side of his pelvis interfering with his range of motion and day-to-day activities.

Kenneth claims he had no choice but to have his hip reevaluated by a new physician at the UPMC Bone and Joint Center. Dr. Brian Hamlin, M.D. decided that due to the pain, increased levels of cobalt and chromium in his blood, and evidence of loosening of acetabular components of the Biomet M2a hip replacement, certain components needed to be removed. This was done in an early revision surgery a little over six years from the date of implantation on Nov. 16, 2016, by Dr. Hamblin.

The plaintiff says he needed to go through a lengthy period of rehabilitation following the Biomet M2a hip replacement surgery that involved physical therapy and healing recovery time.

Because of his alleged pre-revision and post-revision losses, Kenneth is holding the defendants liable for his physical pain, suffering, and compromise which includes some soft tissue and bony tissue destruction, metal fretting and blood poisoning. He is also claiming damages for loss of enjoyment of life, loss of income and earning power, and the limitation he experienced to engage in a full range of activities.

Kenneth brings the following counts against the defendants:

• Count 1: Information Negligently Supplied for the Guidance of Others
• Count 2: Misrepresentation
• Count 3: Negligence
• Count 4 and 5: Strict Liability–Failure to Warn, Design and Manufacturing Defect
• Counts 6 and 7: Breach of Implied and Express Warranty

He is asking for a trial by jury with a favorable judgment on his behalf and compensatory award according to evidence provided.

Device History

The Biomet M2a hip replacement prosthetic was cleared for sale domestically as a result of the U.S. Food and Drug Administration’s (FDA) 510k process. This process doesn’t rely upon clinical safety trials but allows a medical device agency to piggyback a device already on the market which is allegedly equivalent.

This supposed equivalency and approval was followed by manufacturer advertising campaigns which promoted the efficacy of metal-on-metal hips. Metal-on-metal hips have since been found to shed metal debris into surrounding tissue, causing pain, inflammation, and metal blood poisoning.

The M2a Hip Replacement Lawsuit is Case No. 3:18-cv-00469 in U.S. District Court for the Northern District of Indiana, South Bend Division.