Recipients of a Zimmer Persona knee replacement with a Persona TM tibial plate may qualify to take legal action following a 2015 recall of the tibial plate.

Zimmer markets the Zimmer Persona knee replacement as a personalized knee replacement designed to consider individual patient needs.

“In a market focused on matching the bone to the implant shape and size, we found that the opposite needed to happen … we need to match the implant to the shape and size of the resected bone,” their website states. The Zimmer Persona knee replacement is supposed to have options so that the surgeon can best fit the implant to the existing bone for an optimal fit.

The Persona Trabecular Metal (TM) tibial plate is a metal component of the Zimmer Persona knee replacement. The tibia plate attaches to the distal end of the tibia by two pegs which are inserted into pre-drilled holes. These pegs are supposed to “grow” into the bone during the healing process and give stability to the implant.

In February 2015, Zimmer recalled the Persona TM tibial plate, a component of the Zimmer Persona knee replacement system. The voluntary recall was issued after Zimmer received reports that the Persona TM tibial plate was causing the Persona knee implant to loosen from its position. According to the FDA, all sizes and lots of the tibial plate, totaling 12,000 units, were affected.

In March 2015, the FDA issued their notice of the recall to consumers and physicisians. The FDA categorized the Zimmer Persona TM tibial plate as a “Class 2 Recall”. Class 2 denotes drugs and devices that cause temporary or reversible harm.

X-rays of units with this problem showed a visible gap between the knee implant and the bone (radiolucent lines), which can be a sign of poor seating. Symptoms of a failing Persona TM tibial plate may include persistent pain, loosening of the device, lack of ingrowth, component failure, loss of mobility, inflammation, knee instability, fracture, and patella tracking issues.

Zimmer said that 38 percent of patients who reported complications had radiolucent lines or underwent revision surgery due to Zimmer Persona knee replacement failure.

A revision knee replacement surgery may solve the problem, but such surgeries come with serious risks. The nature of the procedure means that damages or unusable bone needs to be removed to re-implant a new knee replacement system.

According to the American Academy of Orthopedic Surgeons, complications of revision surgeries include pain, swelling, stiffness infection, blood clots, bone loss, fractures, leg length discrepancies, and reduced range of motion. More serious complications include damage to nerves or blood vessels, pulmonary embolisms, lung complications, lung complication, or stroke. In addition to potential complications, revision knee surgery also means medical bills, time off work to heal, and time away from friends and families.

Patients who received a Zimmer Persona knee replacement that included the Persona TM tibial plate between 2012 and 2015 may qualify to take legal action. Compensation may be available for medical bills, lost wages, pain and suffering, and more.