The FDA announced in March 2015 that Zimmer Biomet had issued a voluntary recall after numerous adverse event reports indicated a component of the Zimmer Persona knee implant system was at risk for coming loose from its initial position. Zimmer initiated this voluntary recall of the Zimmer Persona TM Tibial Plate in February 2015, affecting nearly trabecular 12,000 metal devices.

The FDA Zimmer knee recall announcement said the agency had classified this as a “Class II recall,” which is reversed for drugs and medical devices that can potentially induce temporary harm to patients. According to the agency, all sizes and lots of the Zimmer Persona trabecular metal tibial plate were included in the FDA Zimmer knee recall.

The tibial plate is part of the knee implant system that attaches on the top of the lower leg bone. It uses two pegs that are designed to connect directly to the surrounding bone tissue. This allows to the knee implant to become a part of the bone without using cement, which is supposed to give the implant stability.

The Zimmer Persona knee implant is often prescribed to patients who have suffered some form of knee injury or degenerative condition that results in painful and limited motions.

Overview of FDA Zimmer Knee Recall

However, aftermarket reports indicate these tibial plates may be prone to loosening and radiolucent lines. Both of these signs indicate improper function of the device, reportedly linked to failure of the two pegs to implant solidly in the surrounding bone.

These injuries were seen in X-rays that showed gaps between the knee implant and the bone. These gaps occur due to “poor seating,” in which the device loosened or becomes out of place.

The FDA Zimmer knee recall described these complications from the X-rays, warning patients and physicians against these symptoms during and after the surgery:

• Radiolucent Lines: The images that show the gaps between the Zimmer knee implant and the bone, with the implant showing early signs of loosening.
• Loosening: The images show the trabecular metal plate was coming loose from its initial implant site, in which Zimmer warned that loosening “is one of the most prevalent causes for revision in total knee arthroplasty.”

The manufacturing company warned that 38% of patients who received Persona trabecular metal plates would need revision surgery due to device loosening. Injuries patients reported from the Zimmer knee implants included:

• Persistent Pain
• Device Loosening
• Lack of In-growth
• Device Failure
• Instability
• Fracture

Patients who experienced these problems most likely had to receive revision surgery, which is considered riskier and more complicated than the initial implant surgery. Even though the FDA Zimmer knee recall may prevent further incidents, it does not help patients who have already been affected by the defective knee implants.

Patients who have been injured by Zimmer knee implants may be able to file legal action against the manufacturer. Potential claimants should contact a medical device lawyer to determine eligibility for a Zimmer knee injury lawsuit.