A voluntary recall of component found inside the Zimmer Persona knee replacement system was conducted after injury reports indicated that poor seating could lead to device failure, forcing patients to undergo revision surgery.

The Zimmer Persona tibial plate recall was announced twice, in February 2015 and March 2015 by the manufacturer and the FDA, respectively. Both of these announcements warned that potential device complications may force the patient to undergo revision surgery to remove and replace the knee replacement device.

The Zimmer Person knee implant recall pertains to the Persona TM Tibial Plate, which is designed so that it can be implanted without the use of cement. The Zimmer Persona tibial plate was approved by the FDA in 2012 to be a treatment option for patients needing to undergo a knee replacement procedure.

The tibial plate instead uses two pegs that attach directly to the tibia for stability, which are meant to grow into the bone and simulate natural movement. However, injury reports indicate that 38% of patients who suffered failure of a Zimmer Persona tibial plate experienced device loosening or had to undergo revision surgery.

Overview of the Zimmer Persona Tibial Plate Failure

The two main problems associated with Zimmer Persona tibial plate failure are radiolucent lines and device loosening. Radiolucent lines are the gaps that appear on the X-ray images showing that the device had moved out of place.

Radiolucent lines are some of the first signs of device loosening, which is when the tibial plate becomes detached from its original position. According to Zimmer, device loosening is “is one of the most prevalent causes for revision in total knee arthroplasty.”

Patients undergoing complications from the Zimmer Persona tibial plates may experience symptoms including:

• Chronic Pain
• Limited Mobility
• Inflammation
• Knee Instability
• Knee Tightness
• Fracture
• Patella Tracking Issues

At this time, it is not known why the device loosening may be occurring. According to the Zimmer Persona tibial plate recall, approximately 12,000 knee implants are subject to recall. The company reportedly received approximately six complaints per 1,000 Zimmer Persona tibial plate patients. More than a third of these injury reports indicated early signs of device failure.

The FDA gave the recall a Class 2 recall designation. This categorization is reserved for medical devices that have been indicated to cause temporary or reversible harm to patents.

Patients who had to undergo revision surgery for alleged Zimmer Persona tibial plate problems have cited various problems including:

• Device Loosening
• Lack of Ingrowth
• Component Failure
• Loss of Fixation

It is important to note that revision surgery puts patients at high risk for infection and may make the patient vulnerable to further knee implant problems. Even though the Zimmer Persona tibial plate recall helps prevent further device failures, it does not help patients who have already had to undergo revision surgery.

Patients who received a Zimmer Persona knee implant between 2012 and 2015 may be able to file legal action against the manufacturer. Potential claimants should contact a lawyer to determine eligibility for a Zimmer Persona tibial plate lawsuit.