Zimmer Persona Knee Lawsuit Filed Over Failure, Need For Revision Surgery

According to allegations raised in a product liability lawsuit filed this month, problems with a Zimmer Persona knee replacement caused a New York woman to experience complications only a few months after the artificial joint was implanted, ultimately leading to the need for revision surgery. 

In a complaint (PDF) filed in the U.S. District Court for the Eastern District of New York on August 11, Laura Woodfield indicates that the Zimmer Personal knee replacement system was defectively designed, resulting in her injuries and its ultimate removal from the market.

Woodfield indicates that she underwent left knee replacement in April 2014, involving the use of a Zipper Persona system, which included a trabecular metal tibial base plate.

Only a few months later, the knee replacement failed and Woodfield had to undergo revision surgery in September 2014. Less than a year later Zimmer Personal knees were removed from the market.

A Zimmer Persona knee recall was announced by the FDA on March 12, 2015, impacting all lots and sizes of the Trabecular Metal Tibial Plate used during knee replacement procedures throughout the United States between November 2012 and early 2015.

According to the manufacturer, the complaint rate was higher than expected when compared to similar devices, acknowledging that about six out of every 1,000 implants may fail. However, some critics suggest that the risk of Zimmer Persona knee problems may ultimately be much higher the longer the implants remain in bodies.

The Zimmer Persona knee replacement system was introduced in late 2012, marketed by the manufacturer as having “[a]natomically accurate components available for a new level of fit tailored to each patient’s unique anatomy.”

The “Personalized Knee” system was designed to provide a high degree of accuracy in it’s fit. However, it now appears that the Zimmer knee design carried an increased risk of loosening, pain and ultimately failure, requiring risky knee revision surgery.

“The subject uncemented Trabecular Metal implant consists of two pegs that, when inserted into the bone, will then grow into or become part of the bone. These pegs are supposed to give the implant stability. This is a deviation from prior knee replacement system designs that feature cemented tibial plates,” Woodfield’s lawsuit states. “Indeed, if the plate is not seated properly, gaps between the plate and bone can occur, which appear in medical imaging as ‘radiolucent lines.’ These radiolucent lines are dark areas on x-rays indicating gaps between the device and the bone tissue. These indicate a ‘poor seating’ of the plate, showing that it’s not staying where intended and is coming loose.”

In these cases, patients can suffer extreme pain, trouble walking and usually require additional surgery to remove or replace the plate, the lawsuit indicates.

Woodfield presents claims for damages caused by design defect, manufacturing defect, failure to warn, negligence, negligent misrepresentation, breach of warranty, and violation of consumer protection laws. She is seeking both punitive and compensatory damages.