Many complications have been reported in individuals implanted with Zimmer’s Persona tibial plate. These reports led to a voluntary recall of the knee implant component in February 2015.

Complaints from patients include that the Persona tibial plate was loosening from the position of implantation.

Other complaints pertained to gaps between the Persona tibial plate and the bone, a sign of “poor seating,” as shown on Zimmer Persona X-rays.

Symptoms of a failing Persona tibial plate include loss of mobility, knee instability, knee tightness, inflammation and persistent pain.

Persona Tibial Plate

The Persona tibial plate is a metal component and part of Zimmer’s total knee replacement system. The device becomes implanted and cemented into the bone while becoming attached to the tibia. The component is comprised of two pegs, providing implant stability. The pegs that are inserted into the bone then “grow” into it.

However, there are two main complaints surrounding the Persona tibial plate that eventually led to the recall. These issues include device loosening and radiolucent lines. The Zimmer persona tibial plate voluntary recall was made in February 2015 because of these two main issues. There have been more than 12,000 trabecular metal components affected by the recall.

The first issue of radiolucent lines pertains to gaps between the Persona tibial plate and the bone to which it becomes inserted. When the Persona tibial plate moves from its intended position, poor seating of the device occurs. Radiolucent lines indicate signs of loosening of the Persona tibial plate.

A second issue corresponds to the loosening of the Persona tibial plate from its position of attachment. Zimmer says of loosening issues that it “is one of the most prevalent causes for revision in total knee arthroplasty.”

The U.S. Food and Drug Administration (FDA) issued an announcement of the company’s voluntary recall in March 2015. The federal agency characterized the Persona tibial plate as a “Class 2 Recall.” This classification is made to categorize devices and drugs that cause reversible or temporary harm.

The recall affected all lots and sizes of the Persona tibial plate.

Zimmer says it received many complaints from patients who either needed to undergo revision surgery or had radiolucent line symptoms because of a defective Persona tibial plate. Reasons individuals were required to undergo revision surgery include:

• Fracture
• Instability
• Globally tight knee
• Lack of ingrowth
• Loosening of device
• Persistent pain
• Patella tracking issues
• Component failure

Additionally, there are added risks and injuries that may come about when undergoing a Persona tibial plate revision surgery. Some of these complications can include:

• Fractures
• Leg length discrepancies
• Blood clots
• Bone loss
• Infection
• Pain and swelling
• Nerve, blood vessel damage, tissue damage

A knee replacement surgery comes with hospital stays, time off work, medical costs and added expenses as well as time away from family and friends. Some patients allege that had they been better warned about risks associated with the Persona tibial plate, complications, adverse side effects, and serious injuries could have been avoided.