A Zimmer Persona tibial plate recall could affect thousands of knee implant recipients.

Zimmer issued a recall of the Persona Trabecular Metal Tibial Plate knee implant component back in 2015. According to the FDA’s website, “an increase in complaints of loosening and radiolucent lines” prompted the Class 2 device recall.

When radiolucent lines are seen on x-rays, these are indications that the implant has moved from where it was originally intended. This movement is called “poor seating” of the component. Radiolucent lines are the first indications that the implant is becoming loose.

The Persona tibial plate recall covers the tibial plate, a component that is implanted into the bone without cement. This Persona tibial plate is attached to the tibia (shin bone) with two pegs that are supposed to encourage bone to grow around them. The idea is the patient’s own bone growth secures the tibial plate and provides stability to the implant.

Unfortunately, reports of radiolucent lines and of the tibial plate loosening allegedly show that many implantations with these components have failed.

Fluid retention around the joint can indicate poor seating. Debris from the ill-fitted implant can wear away and settle into the cracks between the tibial plate and the bone. The pegs from the defective tibial plate allegedly can move around inside the tibia and damage the bone with even the slightest movement.

Zimmer reported that 38 percent of patients who reported problems to the company had symptomatic radiolucent lines or underwent revision surgery due to Zimmer Persona tibial plate failure. Among the issues resulting in revision surgery are:

• Persistent pain
• Device loosening
• Lack of ingrowth
• Failure of a component
• Loss of fixation
• Globally tight knee
• Instable knee
• Bone fracture
• Tracking problems with the patella

Even though knee revision surgery to replace components involved in the Persona tibial plate recall can resolve the issues, revision surgery has its own risks.

Those enduring a second knee replacement surgery are at a higher risk of pain and swelling, infection, blood clots, bone loss and fractures. A subsequent knee replacement surgery also places the patient at higher risk of nerve, tissue or blood vessel damage. Some patients experience leg length discrepancies because the pegged portion of the tibial plate digs into the tibia, affecting the bone’s length upon revision surgery.

Patients who have another knee replacement surgery due to the Persona tibial plate recall will have the additional expense of another stay at the hospital and another round of occupational and/or physical therapy. They also will need more time off work and away from family and friends. These impositions could have been avoided if the tibial plate had not been defective in the first place.

If you have been affected by the Persona tibial plate recall and have undergone revision surgery as a result of this defective part, you could qualify for compensation through legal representation.