The Zimmer Persona knee system is a knee replacement prosthetic that has been recently associated with serious device complications and early device failure. Numerous patients have alleged they had to undergo revision surgery not long after implant with the Zimmer Persona knee system, which has spurred a class action investigation against Zimmer.

The growing concern surrounding the knee replacement device had eventually spurred the company to initiate a voluntary recall of certain components of the Zimmer Persona knee system.

More specifically, Zimmer had voluntarily recalled the Zimmer Persona Trabecular Metal Tibial Plate component in their system in January 2015. The Zimmer Persona recall affected approximately 12,000 Trabecular Metal Tibial plates.

The FDA had announced the recall of the device component several months later, and gave it a Class II designation. This recall classification is designated for medical products that have caused temporary or reversible harm to patients.

Zimmer had decided to recall the device component after it was discovered that the Persona Tibial Plate were causing the knee replacement system to loosen and ultimately fail. The two main complications that were identified in the Zimmer and FDA recall were:

• Radiolucent Lines, or the gaps or spaces that can be seen in X-ray images, which are between the bone and the knee replacement system. Radiolucent lines are a sign of “poor seating,” which is when the device dislocates from its original implant position.
• Device Loosening occurs when the Trabecular Metal Tibial Plate becomes loose from its original implant position, with Zimmer describing this problem as “one of the most prevalent causes for revision in total knee arthroplasty.”

According to the FDA, the recall affects all sizes and lots of the Zimmer Persona Trabecular Metal Tibial plate.

Overview of Zimmer Persona Knee System Problems

The Trabecular Metal Tibial Plate is one of the main components of the Zimmer Persona knee system; it is the component that allows the knee replacement to attach to the bone without using cement.

The Zimmer Persona tibial plate instead attaches to the tibia by using two pegs that are directly inserted into the bone and are supposed to “grow” into it. This is supposed to give the Zimmer Persona knee system stability and ultimately allow patients to return to their normal active life.

However, the numerous injury reports from patients indicate that the Trabecular Metal Tibial Plate may seriously complicate their health, and that patients may face an increased risk of premature device failure.

According to Zimmer, approximately 38 percent of patients who reported failing tibial plates reported that the Zimmer Persona knee system had developed radiolucent lines or had to undergo revision surgery due to device failure. Patients who experience Zimmer Persona knee system failure may experience painful symptoms including:

• Persistent Pain
• Device Loosening
• Lack of Ingrowth
• Device Component Failure
• Globally Tight Knee
• Instability
• Inflammation
• Limited Mobility
• Patella Tracking Issues

Patients who experience Zimmer Persona knee system failure will most likely have to undergo revision surgery, which is considered riskier than the initial implant surgery because of the risk of infection. Patients who had to undergo revision surgery due to Zimmer Persona knee system failure may be able to file legal action against Zimmer.