A component of the Zimmer Persona knee replacement prosthetic unit known as the tibial plate was voluntarily recalled by the Zimmer Co. in 2015. This recall affected nearly 12,000 trabecular metal tibial plates—a critical part of the prosthetic whole.

The TM tibial plate of the Zimmer Persona knee replacement lies on top of the resurfaced tibia—the larger of two lower human leg bones. This plate or shelf was designed with two bottom evenly-spaced pegs which, when implanted into the bone, are supposed to grow into and stabilize the surface.

This Zimmer Persona knee replacement tibial plate is differentiated from other tibial prosthetic surfaces which have utilized surgical cement to adhere a peg or pegs into the bone.

Reported Problems with the TM Tibial Plate

The Zimmer Persona knee replacement was fast-tracked through the U.S. Food and Drug Administration’s medical device approval process by piggy-backing an already-approved device through the 510(k) review process. This process allows a medical device manufacturer such as Zimmer to bypass more rigorous testing by relying on the record of a similar product in circulation.

It wasn’t long after its FDA approval in 2012 that problems started showing up in recipients of the prosthetic unit. A good percentage of implants were a source of ongoing pain and discomfort in total knee replacement (TKR) patients long after what would be considered a normal time window of healing had passed.

Upon investigation using X-ray imaging, radiolucent lines were evident, indicating that the Zimmer Persona knee replacement TM tibial plate was moving from its original placement. The lines were a sign of gaps forming between the bone and the plate—a wake-up call warning that further prosthetic loosening could follow.

The Zimmer company received many complaints from former TKR patients that required knee revision surgeries. These revision surgeries involved removal of the Persona Knee TM tibial plate and replacement with another prosthetic component or entire unit.

The voluntary recall was started in January 2015 and formalized by the FDA with an announcement in March of the same year. The FDA classified the action as a Class 2 Recall, reserved for medical devices that cause temporary or reversible harm.

When total knee revision surgery is undertaken, it presents the patient with additional risks. The complete removal of a prosthetic unit can result in bone tissue loss, and nerve and vessel damage.

Additionally, there is a risk of infection and blood clots which can have serious and even fatal consequences. Finally, a revision patient could spend the rest of his or her life with a notable difference in the length of their legs causing a limp or need for assistive walking device such as a cane.

If you were a recipient of a Zimmer Personal knee replacement prosthetic with a TM tibial plate between 2012 and 2015 and have experienced pain and inflammation, instability, or even fracture, you may have a legal claim.