The FDA has recalled the Zimmer Persona Trabecular Metal Tibial plate knee implant, and this has affected thousands of patients.

Last year, the U.S. Food and Drug Administration announced a Class II Recall of the Zimmer Persona Trabecular Metal (TM) Tibial plate knee implant because, they claim, the device has led to many complications for patients and early loosening.

The FDA announced this recall for all of the lots and sizes of the Zimmer Persona knee implant device and, according to the FDA, this involves nearly 12,000 knee implant devices.

The FDA says, “Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution.”

A Class II recall affects devices that may not be life-threatening in nature, but can cause adverse health consequences and complications.

Some of the major complications associated with the Zimmer Persona TM Tibial plate knee implant have to do with radiolucent lines. Radiolucent lines, visible in X-rays, are large gaps between the device components themselves or between the components and the bone. Radiolucent lines may mean that the patient must undergo revision surgery.

Radiolucent lines can also cause joint fluid buildup and tissue and implant wear. Debris can gather in the gaps which can lead to bone damage. This type of bone damage is called osteolysis which is a marker of failure of the knee implant.

If an implant loosens, swelling, bone damage and severe pain may result.

When the recall was issued, hospitals, doctors and surgeons received notices that all of the Zimmer Persona Trabecular Metal tibial plate knee implants were supposed to be located and quarantined.

Patients have also reported other complications associated with the Zimmer Persona knee implant including persistent pain, lack of ingrowth, component failure, loss of fixation, fracture, globally tight knee, instability and patella tracking issues.

How does the Zimmer Persona Trabecular Metal Tibial Plate Knee Implant Work?

This device is implanted into the bone without the more traditional use of cement. This implant is attached to the tibia bone, one of the bones in the lower leg, via two pegs that are implanted into the bone. These pegs are supposed to grow into the bone and give the implant further stability.

If you or someone you love has received a Zimmer Persona Trabecular Metal Tibial Plate knee implant and have experienced adverse effects such as loosening, instability or fracture, you may benefit from speaking to a Zimmer Persona attorney. Because of your injuries, you may be entitled to legal compensation.