A recent Zimmer Persona knee lawsuit claims that the joint replacement device is defective and causes early implant failure.

Plaintiff Jamie S. was reportedly implanted with the Zimmer Persona knee in August 2016. However, allegedly due to complications allegedly caused by the defective knee implant, Jamie underwent revision surgery in February 2017.

“As a result of the failed medical Device, the revised knee implant is not functioning at its full potential, due to the loss of bone cartilage, surface, and tissue from the original defective Persona device,” the Zimmer Persona knee lawsuit claims.

The Zimmer Persona knee is a knee replacement implant that was approved by the FDA in 2012. The device was reportedly approved through the agency’s 510(k) process which allows products fast track approval if they are proven to be similar to a device that has already been approved. This process allows companies to skip extensive testing.

Zimmer states: “By combining intuitive design with engineering excellence, the Persona Knee System supports unparalleled levels of personalization, empowering surgeons to restore the unique identity of every knee.”

However, the porous, uncemented tibial plate involved in the Zimmer Persona knee design reportedly caused loosening and eventual implant failure – prompting a recall of the tibial plate in 2015. The recall reportedly included around 11,700 Persona tibial plates in all sizes.

In the FDA recall announcement, Zimmer stated that the cause of the recall was “an increase in complaints of loosening and radiolucent lines”.

Radiolucent lines occur when the tibial plate component loosens from the tibia, resulting in gaps visible on an X-ray. These gaps are called radiolucent lines and often indicate that an implant is loosening to the point of failure.

At the time of the recall, the complaint rate was reportedly 6 complaints per 1,000 devices. Of those, 36 percent of the complaints reportedly identified symptomatic radiolucent lines, 28 percent identified asymptomatic radiolucencies, 8 percent subsided, and 28 percent were inconclusive.

Loosening of implant components can cause a variety of complications including joint instability, pain, reduced range of motion, and other debilitating side effects. These side effects may require revision surgery to fix, risking further injury to consumers.

Revision surgery involved the removal of a failed implant and the replacement with a new device. If implant failure has caused damage to tissues, surgeons have to take extra care not to cause further harm. If the bone mass has been compromised by implant failure, a surgeon may have to graft new bone so that the new implant can be fixed in the joint.

Overall, revision surgery includes significant uncertainty and difficult recovery. Additionally, revised joint replacements are less likely to succeed when compared to initial replacement – meaning that individuals may need further revision surgery.

Jamie accuses Zimmer of design defect, failure to warn, manufacturing defect, negligence, negligent misrepresentation, and breach of warranties. Her Zimmer Persona lawsuit seeks compensatory damages, economic damages, punitive damages, interest, court costs, and attorneys’ fees.

The Zimmer Persona Knee Lawsuit is Case No. 2:19-cv-06863-JMV-JAD in the U.S. District Court for the District of New Jersey.