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With its product not even on the market for three years, Zimmer announced a recall of its Persona Personalized Knee System in February 2015 over the failure of the Persona Trabecylar Metal Tibial Plate, one of its key components. The FDA then followed this announcement a month later, notifying surgeons of a Class II recall.
An increase in complaints concerning radiolucent lines in X-rays and loosening prompted the FDA to make this decision. Statistically, the device, designed to mimic the knee’s natural motion, had six complaints for every implant. Out of this amount, 36 percent involved radiolucent lines or revision surgery.
Because of these factors, several patients have come forward to file lawsuits against the company.
Background
The FDA approved the Persona Knee System in 2013, and the device lasted until January 2015. Zimmerman marketed it as a personal knee system, which, compared to other implants, offered a greater range of sizing options and came with integrated intelligent instruments and side-specific kinematics. Surgeons could also implant it without using cement.
In allowing the user more natural motion of his or her knee, the implant further targeted a younger, more active demographic. But, not long after it appeared on the market, patients started to suffer from various complications, including:
- Loosening of the tibial component
- Gaps between the plate and the patient’s bone
In both instances, revision surgery removing the full implant became necessary to replace the tibial component.
Additionally, radiolucent lines showed up during X-rays. Should these go unaddressed, joint fluid, tissue, and debris have potential to become lodged in the cracks. Over time, not treating this condition leads to osteolysis, an early indicator of implant failure. Patients may also experience pain, swelling, tissue, and bone damage, which could lead to immobility and additional injuries.
After multiple reports, the FDA issued a Class II recall, which indicates the product may result in temporary or medically reversible health consequences to the patient. This particular recall encompassed 11,700 units.
Lawsuits
Although a class action lawsuit has yet to go into effect, various patients have started filing individual claims against Zimmer. Cases allege the manufacturer didn’t have its device fully tested and researched for side effects before running it by the FDA, which approved it for its similarity to other knee implants. Plaintiffs, further, are seeking compensation for additional revision treatments, pain, and suffering.
