After the Zimmer Persona knee implant system spent less than three years on the market, Zimmer issued a voluntary Zimmer Persona tibial plate recall due to reports of serious side effects.

An increasing number of patients were experiencing severe side effects including severe pain, premature device failure, and loosening of the implant. Some complications reported around the time of the Zimmer Persona tibial plate recall include device failure, revision surgery, pain with mobility, malalignment, decreased mobility, severe pain, and loosening of the implant.

X-rays of patients with the Zimmer Persona system signs of “poor seating” of the tibial plate, visible as gaps between the bone and the knee implant.

Overview: Zimmer Persona Tibial Plate

When Zimmer’s Persona tibial plate was first introduced on the market it was marketed as “the Personalized Knee System” and introduced as a “new era of personalization.”

The system allows surgeons to personalize the implant to fit the patient’s needs, with the goal of the system being to have it function as close as possible to a real human joint.

According to Zimmer’s advertisement brochure, the Persona Knee System “was designed to minimize the compromises experienced with yesterday’s standard knee systems.”

The Zimmer Persona Trabecular Metal tibial plate is the part of the implant system that attaches to the tibia. The tibial plate comes with two pegs that function to provide implant stability. The two pegs are inserted into the bone and “grow” into the bone after implantation.

Zimmer Persona Tibial Plate Recall

In March 2015, the U.S. Food and Drug Administration (FDA) announced Zimmer’s voluntary recall after the company received an increasing number of patient complaints about radiolucent lines and loosening of the implant.

The FDA announced a Class II recall of Zimmer’s Persona Trabecular Metal Tibial Plate, part of the Persona Knee System. According to the FDA, a Class II recall affects a medical device that “may cause temporary or medically reversible adverse health consequences.”

Zimmer initiated the voluntary recall announcement in February 2015, and the Zimmer Persona tibial plate recall affected approximately 12,000 components of all sizes and lots. Loosening of the device and radiolucent lines were two of the main problems being reported.

The loosening of the trabecular metal plate refers to its detachment from where it was originally implanted. According to Zimmer, loose components are “one of the most prevalent causes for revision in total knee arthroplasty.”

Radiolucent lines, visible on X-ray, are a sign of “poor seating.” They show up on X-rays as gaps between the bone and the knee implant component. When the implant moves from where it was implanted, poor seating occurs.

Thirty-eight percent of patients who complained to Zimmer about failing Persona Trabecular Metal Plates underwent revision surgery or experienced symptoms of radiolucent lines.

Some reasons patients cited for undergoing revision surgery include: loosening of the device, persistent pain, lack of ingrowth, loss of fixation, globally tight knee, fracture, instability, and patella tracking issues.