A New York woman has filed a metal on metal hip replacement lawsuit against Biomet alleging the medical device caused her to suffer severe injury.

Plaintiff Rosalie L. is a 61-year-old woman who had hip replacement six years ago. She was implanted with a Biomet M2a Magnum Hip Replacement System in her right hip.

Following her hip surgery, Rosalie suffered from severe and constant pain and suffering, swelling, tissue damage, synovial fluid buildup, lack of mobility and metal poisoning (also known as metallosis), the metal on metal hip replacement lawsuit states.

Additionally, Rosalie had to have revision surgery to remove the allegedly defective device and replace it with a new hip implant.

As a result of the pain, injury and lack of mobility, Rosalie faced emotional distress as well as loss of enjoyment of her life, the lawsuit claims.

According to her metal on metal hip replacement lawsuit, Biomet’s M2a Magnum Hip Replacement System is a class III medical device that was required to undergo rigorous testing prior to its release on the market.

However, a manufacturer can bypass rigorous premarket approval if the medical advice is “substantially equivalent” to a similar device that has already been approved.

Consequently, Biomet was able to manufacture, market and sell its Biomet M2a Magnum Hip Replacement System “with virtually no clinical or non-clinical trials or FDA review of the hip replacement System for safety and effectiveness,” the metal on metal hip replacement lawsuit states.

Essentially, Rosalie’s metal on metal hip replacement lawsuit states that the medical device used in her surgery was not equivalent to the previously approved hip replacement systems manufactured by Biomet, thus causing unnecessary damage due to an allegedly defective device.

Unlike other hip implants, the Biomet M2a Magnum Hip Replacement System is made with metal parts that touch. Other hip implants are also made with metal components, however, the metal components are separated by a liner, usually made of polyethylene, that prohibits the metal pieces from actually touching.

When the metal pieces touch during the normal movement of the ball and socket artificial hip joint, small flakes of metal shed from the implant. This metal debris from the implant has been implicated in causing a number of side effects in the patient, as it was in Rosalie’s case.

If the metal gets into the surrounding tissue, it can cause necrosis, or death, of the tissue. This can then cause the device to become loose as it moves from its original position.

Swelling and inflammation is commonly seen as well as damage to the surrounding tissue, even beyond the tissue necrosis.

Metallosis is caused by elevated levels of metal in the body. Typically, cobalt and chromium are found at high levels in patients, and these high metal levels can lead to systemic effects.

Things like endocrine disruption and organ damage may result from high levels of metal in the body.

Rosalie has brought forth several counts against Biomet including negligence, strict products liability, breach of implied warranty, fraudulent misrepresentation, deceptive business practices under New York General Business Law, fraudulent concealment, false advertising, negligent misrepresentation, fraud and deceit.

The plaintiff is seeking compensatory damages, punitive and/or exemplary damages, treble damages, attorneys’ fees and costs and any additional relief as deemed proper by the court.

The Metal on Metal Hip Replacement Lawsuit is Case No.3:16-cv-00503, in the U.S. District Court for the Northern District of Louisiana, South Bend Division.