The tibial plate of the Zimmer Persona knee implant has been the subject of recent concern in the patient population and medical community due to reports of early device failure and need for revision surgery.

Zimmer Biomet recently initiated a recall of the tibial plate of the Zimmer Persona knee implant in March 2015, allegedly due to reports of symptoms suggesting tibial plate failure. This is a considered a Class 2 recall, which is designated for medical products that have been indicated to have caused reversible or temporary harm in patients.

The Zimmer Persona knee implant tibial plate recalll affects 11,658 units containing the Persona Trabecular Metal Tibial Plate component. The tibial plate is the part of the implant that connects to the lower leg without the use of cement.

The tibial plate contains two pegs that insert directly into the bone. This is supposed to allow the implant to naturally “grow” into the bone and ultimately give stability and function to the Zimmer Persona knee implant.

However, these tibial plates have been allegedly failing inside patients, reportedly leading to poor seating and device loosening. Signs of possible failure of the tibial plate may appear on X-ray as radiolucent lines.

These lines appear in the gaps between the knee implant component and bone, and they may be signs of poor seating or loosening. According to Zimmer, device loosening “is one of the most prevalent causes for revision in total knee arthroplasty.”

Overview of Zimmer Persona Knee Implant Problems

Upon receiving reports of radiolucent lines and loosening, Zimmer Biomet initiated the Zimmer Persona knee implant tibial plate recall to prevent further injuries.

The tibial plate recall was initiated after the company had received numerous injury reports indicating early device failure, requiring many patients to undergo revision surgery.

The Zimmer Persona knee implant was approved by the FDA in 2012, indicated for patients suffering from damaged knee joints and wanting to have their mobility restored. Knee replacement surgery is a typical medical procedure, with millions of Americans seeking to restore the patient’s sense of normalcy.

On average, patients will have to have a knee replacement implant explanted and replaced between eight and 10 years. However, some patients who opted for the Zimmer Persona knee implant reportedly had to undergo revision surgery much sooner.

The Zimmer Persona knee implant was approved through the FDA’s 510(k) process, which allowed it quick entry into the United States market. Under the 510(k) process, a new medical device may be eligible to bypass certain testing requirements if it proves to work at least on an equivalent level with a similar product already on the market.

Critics of this process allege it did not allow for a sufficient safety profile for the Zimmer Persona knee implant. Zimmer Biomet has faced legal challenges from patients who allege the company either knew or should have known about potential knee implant failure.