Knee replacement patients who received an implant subject to a Zimmer Persona knee implant recall could be in for significant and painful complications.

In March 2015, the FDA announced a Zimmer Persona knee implant recall affecting the implant system’s trabecular metal tibial plate. The tibial plate is the part of the implant system that attaches to the top of the lower leg bone, using two pegs designed to grow into the surrounding bone tissue.

Aftermarket reports said these tibial plates had been subject to premature loosening and radiolucent lines, both signs of improper implant function. In some reported cases, the two tibial pegs failed to grow into the surrounding bone.

Loosening of an implant can lead to significant pain and may require revision surgery. Radiolucent lines are evidence found in X-rays of a gap between the tibial plate and the adjacent bone. This gap can form when the plate migrates away from its proper position due to poor seating.

Zimmer initiated the recall voluntarily in late January 2015, the FDA said. The Zimmer Persona knee implant recall affected close to 12,000 individual units from all lots and sizes that were distributed between 2012 through the beginning of 2015. All units affected by the recall were to be removed from distribution.

The FDA classifies this Zimmer Persona knee implant recall as a Class II recall, which applies to situations where a product “may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.”

Zimmer Persona Knee Implant Recall Seeks to Avoid Implant Complications

Problems like those reported with the Zimmer Persona components can cause the implant to fail to remain properly implanted. Failure of ingrowth can cause components to come unfixed, possibly leading to mechanical failure of the implant.

These problems can cause a patient to experience instability, fractures, chronic pain, patella tracking problems, and discomfort or tightness in the knee.

According to Zimmer, loosening of implant components is one of the most prevalent causes of the need for revision surgery among knee arthroplasty patients.

Revision surgery comes with its own set of complications. It tends to be more involved than an original knee implant surgery. For that reason, it can put the patient at a greater risk for complications and may require a significantly longer recovery time.

Revision surgery patients are more likely to experience pain, infection, blood clots or fractures. They may also be at a greater risk for loss of bone or damage to surrounding nerve or muscle tissue, and they could end up with a leg length discrepancy.

Complications from a defective knee implant can be extremely burdensome on the patient. These complications may far exceed what the patient was led to expect from the product information provided by the implant’s manufacturer.

Persons who suffered complications following implantation of a Zimmer Persona implant system may benefit from a consultation with a knowledgeable medical device attorney. Compensation may be available to cover losses like medical expenses, lost income, and pain and suffering.