The tibial plate component of the Persona total knee system was recalled due to reports of loosening and radiolucent lines.

Made by Zimmer, the Persona total knee is typically used in patients suffering from damaged or deteriorated knee joints. The Persona system is unique because it does not use cement to attach to the bone. The Persona knee replacement system attaches by way of the Trabecular Metal (TM) tibial plate component, which consists of two metal pegs that insert directly into the bone. The pegs then connect directly to the bone, holding the implant in place.

However, the Trabecular Metal tibial plate component has allegedly been causing complications in patients implanted with the Persona knee replacement system, eventually spurring a recall from the manufacturer.

Overview of Persona Total Knee System Problems

Zimmer issued a voluntary recall of the Persona Trabecular Metal Tibial Plate recall in February 2015, after receiving injury reports indicating the tibial plate was loosening and shifting from its initial implant position. This shift in position often leads to device failure and need for revision surgery.

The FDA announced the recall in March 2015, classifying it as a Class 2 recall, which is designated for problems that could lead to reversible or temporary harm for patients.

The recall affected approximately 12,000 Trabecular Metal tibial plate components potentially at risk for device loosening and premature device failure. Zimmer initiated this recall after receiving injury reports describing the following complications:

• Radiolucent Lines: Gaps or spaces that can be seen in X-ray images, which appear between the Trabecular Metal tibial plate and the bone. This is a sign of “poor seating,” which is an early sign of device loosening.
• Device Loosening: This occurs when the Trabecular Metal tibial plate shifts and detaches from its initial implant position, with device failure often following. Zimmer states that device loosening “is one of the most prevalent causes for revision in total knee arthroplasty.”

These complications often cause debilitating pain and other side effects, with revision surgery typically being the only way to resolve them. It is important to note that revision surgery is considered riskier than the initial knee replacement surgery, because the risk for infection is higher.

According to Zimmer, approximately 38 percent of patients had developed radiolucent lines or had to undergo revision surgery after receiving a Persona total knee replacement system. Patients who had the Persona knee replacement system implanted can watch for unusual symptoms including:

• Persistent Pain
• Limited Mobility
• Inflammation
• Knee Instability
• Knee Tightness
• Globally Tight Knee
• Fracture
• Patella Tracking Problems