A knee replacement patient has filed a lawsuit against Zimmer Biomet alleging that the medical device company manufactured and distributed faulty and defective total knee replacement devices.

The product in question is the Zimmer Persona Knee System. Plaintiff David S. was implanted with Zimmer knee implants in both knees in January 2015 when he underwent a bilateral total knee arthroplasty at Advocate General Hospital, located in Park Ridge, Cook County, Illinois.

According to the Zimmer lawsuit, soon after David S. had had the bilateral total knee replacement done, he suffered debilitating pain and suffering.

The complaint contends that “the plaintiff suffered significant pain and debilitation caused by loosening of the tibial components of his total knee arthroplasties.”

Operative findings had found, moreover, “an absence of bone ingrowth on the undersurface of the tibial component, including complete absence on the lateral peg of the tibial component,” the lawsuit further states.

Accordingly, David S. maintains that he had soon had to have revision surgery of the tibial component in October 2015.

Zimmer Persona Recall

In February 2015, the lawsuit alleges that Zimmer had components of the Persona Knee System recalled. These components included the trabecular metal tibial plate, due to alleged “high rates of failures relating to loosening and radiolucent lines.”

The Zimmer Persona recall instructed quarantine of all medical devices, specifically modular brackets and instruments, and to contact the company for removal of these products during the recall. Reports, further, indicate that the Zimmer Persona recall had been announced and issued voluntarily.

The Zimmer Persona recall had allegedly included modular brackets and instruments due to incidences of radiolucent lines and loosening that were purportedly higher than what Zimmer had initially expected.

According to alleged reports, the Zimmer Persona total knee replacement implant would loosen from where it had been originally implanted. Additional MRI and X-ray reports show that gaps would occur between the bone and the implant. This consequence is termed a condition of “poor seating.”

Loose components and the alleged loosening of the trabecular metal plate from where it had been implanted, is one of the most common causes for a total knee arthroplasty revision surgery.

Radiolucent lines are also indications for when an implant begins to loosen up, and when spaces or gaps begin to appear between the Zimmer Persona Knee replacement implant and the bone.

The gaps or spaces are allegedly termed, and indicate the condition of “poor seating.” This occurs when the implant replacement repositions itself and moves from its intended location. Radiolucent lines appear when the implant begins to loosen up and the spaces and gaps appear.

Reports further explain that although revision surgery may help repair the issues resulting from a defective implant device, there are other complications and sets of additional risks that come along with revision surgery.

Some of these risks include: fractures, pain or swelling, bone loss, blood clots, and infection.

The Zimmer Persona Recall Lawsuit is Case No. 1:17-cv-04377 in the U.S. District Court for the Northern District of Illinois.