A married couple filed a Zimmer Persona lawsuit this January in U.S. District Court in the District of New Jersey.

The Zimmer Persona lawsuit concerns the knee replacement prosthetic device by the same name which was approved by the U.S. Food and Drug Administration (FDA) in 2012 without the full requirements for extensive pre-market safety testing.

The approval was made under the 501(k) program, which allows for a new device to piggyback on an already marketed device if it is “substantially equivalent” to that older device. Zimmer named its NexGen knee system, as well as the DePuy Attune knee system, as preexisting commercially similar medical devices when submitting their application to the FDA.

According to the narrative of the Zimmer Persona lawsuit, the new device had a porous tibial plate whose two pegs were not cemented into the lower leg bone. This made it clearly different from the devices being cited as equivalent, the plaintiff claims.

The tibial plate rests on the top of the main lower leg bone and has at least one, or in this case two stems, which are implanted into the bone for stabilization of the joint during movement.

Some stem versions are cemented as part of the implantation process, and others rely upon ingrowth of bone tissue to hold it in place. The Zimmer Persona knee is the latter type. The tibial plate provides a rocking surface for the rest of the prosthetic unit to work.

Zimmer Persona Lawsuit Cites Prosthetic Recall History

The Zimmer Company recalled the Persona knee system in 2015 after being commercially available for just three years. Severe complications were so numerous that patients were being subjected to early knee revision surgery and removal and replacement of the prosthetic out of necessity.

These issues forced recipients to endure more pain and suffering as well as take on risks such as potential blood clots, loss of bone tissue, and leg length differences. All told, 11,700 units had been distributed or implanted at the time of the recalls.

Anthony’s Zimmer Persona lawsuit talks about radiolucent lines showing up on X-ray that indicate a generalized loosening of the trabecular tibial plate and the possibility of gaps between the plate and the bone.

The radiolucent lines reflected that the plate was poorly seated, leading recipients to have grave difficulties with ambulating and carrying on with the activities of daily living.

Anthony V. had his left knee replaced in July 2014 with a Zimmer Persona prosthetic. Less than two years later, he had to have it replaced in a revision surgery. He lost bone tissue which compromised the full functioning of the new prosthesis.

The plaintiffs are bringing the following actions against the Zimmer Company: Product Liability Act (PLA) claims of defective design, failure to warn, manufacturing defect, negligence, negligent misrepresentation, breach of express and implied warranty, as well as warranty of fitness for ordinary use, fraudulent misrepresentation, fraudulent concealment, fraud, punitive damages, and loss of consortium.

Anthony and his wife are asking for a trial by jury with compensatory and punitive damages awarded according to evidence provided. They hope for consideration of both their economic as well as physical and psychological suffering.

The Zimmer Persona Lawsuit is Case No. 1:18-cv-00550 in the U.S. District Court, District of New Jersey, Camden Division.