Problems with the Persona tibial plate, a component of the Zimmer Persona knee implant system, could lead to implant loosening.

Zimmer issued a voluntary recall of its Zimmer Persona TM Tibial Plate in January 2015. The FDA announced the recall as a Class 2 recall in March 2015 because the part could cause temporary or reversible harm.

This particular component is anchored by two pegs that were intended to connect with the surrounding bone. Because no surgical adhesive of any kind is used, the patient’s bone growth is supposed to become a natural stabilizing force.

X-rays of patients experiencing issues show small gaps between the component and the bone, which indicates “poor seating.” These radiolucent lines indicate the implant has moved from its original position and is beginning to loosen.

When poor seating becomes an issue, the joint can develop fluid retention. Possible debris wearing away in the implant can settle into the tiny crevices between the Persona tibial plate and the bone. As the pegs move ever so slightly, pain and bone damage can occur.

Zimmer reported 38 percent of patients who suffered an implant failure had symptomatic radiolucent lines or underwent revision surgery due to problems with the Persona tibial plate.

Patients experiencing any of the following symptoms could be candidates for revision surgery:

• Persistent pain
• Device loosening
• Lack of ingrowth
• Component failure
• Loss of fixation
• Globally tight knee
• Instability
• Fracture
• Patella tracking issues

Failed Persona Tibial Plate Leads to Revision Surgery

When a Persona tibial plate becomes loose, the patient’s only recourse is revision surgery.

The knee is a relatively intricate part of the body with not a lot of bone area. A second knee surgery can leave a patient at a higher risk for complications. Pain and swelling are factors in most any type of surgery, but the risks of infection, blood clots and bone loss increase, too. Nerves, surrounding tissue, and blood vessels are at a greater risk of damage in knee revision surgery.

All sizes and lots of the Persona tibial plates are covered by the recall, which affects nearly 12,000 devices.

Zimmer has had to issue recalls on components in the past. The company’s MIS tibial parts were recalled in 2010 because of device loosening. That recall affected nearly 70,000 components.

Defective screws that could loosen and lead to knee implant failure led to the 2014 Zimmer recall of nearly 40,000 NexGen Knees. These implant devices originally were advertised as well-suited to patients who enjoyed an active lifestyle.

Zimmer is facing a number of lawsuits because patients are enduring painful complications from the failed Persona tibial plate and requiring revision surgeries years earlier than they ever anticipated.

Patients who received the cementless Persona tibial plate as part of a total knee replacement completed between 2012 and 2015 could qualify to participate in a lawsuit against Zimmer.