A Zimmer Persona tibial plate recall was conducted in March 2015 when the company voluntarily withdrew this medical device component from the market. The Zimmer Persona tibial plate recall was conducted after numerous injury reports were submitted by patients who indicated there were two major problems leading to device failure.

The FDA announced this Zimmer Persona tibial plate recall the next month, with the agency classifying it as a Class 2 recall. This classification is designated for medical devices that have been indicated to cause temporary or reversible harm to patients. In addition, the FDA stated that all sizes and lots of the Zimmer Persona tibial plate were affected.

Also known as the Zimmer Persona Trabecular Metal (TM) tibial plate, it is a metal component of the Zimmer Persona knee replacement system and allows the device to be implanted without using cement. The device uses two metal pegs that are directly inserted into the tibia which is meant to “grow” into the bone during the attachment process.

This is supposed to allow for normal knee movement and problems, and give stability to the knee replacement system. Even though the Zimmer Persona knee replacement system has helped numerous patients, devices with the affected tibial plate could pose serious threats to patients.

Overview of Zimmer Persona Tibial Plate Recall

The Zimmer Persona tibial plate recall withdrew almost 12,000 tibial plates from the market, with patients reporting two major complications that sometimes required revision surgery to fix:

• Radiolucent Lines: Lines or gaps that can be seen on X-ray images, which are the spaces between the tibial plate component and the bone. This is a sign of “poor seating”, which allows the tibial plate to move out of the implant site and is often an early sign of device loosening.
• Device Loosening: When tibial plate comes loose from where it was originally attached, with Zimmer calling this complication “one of the most prevalent causes for revision in total knee arthroplasty.”

If the Zimmer Persona tibial plate component comes loose, patients can experience a number of painful symptoms that can make daily life very difficult, including:

• Chronic Pain
• Mobility Loss
• Inflammation
• Knee Instability
• Knee Tightness
• Component Failure
• Loss of Fixation
• Instability
• Fracture
• Patella Tracking Issues
• Inflammation

It is important to note that the revision surgery is considered riskier than the initial knee replacement surgery, due to the higher risk of infection.

Knee replacement surgery is one of the most common prosthetic procedures done in the country, with many patients needing to undergo the surgery to fix knee problems related to traumatic injury or joint deterioration disease.

Given the importance of this surgery and need for knee replacement prosthetic, the problems associated with the Zimmer Persona tibial plate are very troubling to the patient population and medical community.

An investigation has been launched for patients who received a knee replacement system that contained a component affected by the Zimmer Persona tibial plate recall.