The Zimmer company manufactures a prosthetic unit for total knee arthroscopies known as the Zimmer Personal Knee Implant System.

The Persona trabecular metal tibial plate, a component of this knee prosthetic, was later voluntarily recalled by Zimmer in February 2015. This voluntary recall was initiated after Zimmer assessed that nearly 38% of recipients who reported tibial plate failure either underwent revision knee surgery or showed radiolucent lines on an X-ray.

With X-ray results revealing radiolucent lines or gaps between the Persona trabecular metal tibial plate and the bone, the implant may need to be replaced.

Most knee replacement prosthetic units are comprised of a femoral component that attaches to the amputated end of the femoral bone, or upper leg bone. This piece then articulates in lieu of the natural femoral end with a flattened surface attached to the amputated top of the tibia, or lower leg bone.

The Persona trabecular metal tibial plate is implanted into the lower leg bone using two pegs for stability. The implantation process heavily relies upon the bone growing around the pegs, so the Personal trabecular metal tibial plate is applied without cement.

The U.S. Food and Drug Administration Recall

The U.S. Food and Drug Administration (FDA) followed up on Zimmer’s voluntary recall of 12,000 units of the Persona trabecular metal tibial plate, announcing it as a Class 2 medical device recall in March 2015.

Class 2 medical device recalls are reserved for devices that cause temporary or reversible harm. Once a defective knee replacement prosthetic is removed and replaced during a revision surgery, it is hoped that the patient will return to an optimal state of health and movement.

Risks of Revision and the Potential for Long-Range Problems

Problems with the Persona trabecular metal tibial plate, as with other failed knee prosthetic parts and units, can create lasting damage for the recipient.

With the need to remove and replace the device comes the possibility of bone and other tissue loss. This loss can make a secondary prosthetic difficult to place as well. It can also cause leg length differences which can throw the center of gravity off for the muscular skeletal system, affecting posture and the function of other joints.

There can also be nerve and blood vessel damage that happens because of the revision surgery. Surgeries requiring general anesthesia are always risky, and the risk is greater with knee or hip arthroscopies because of blood clots.

Blood clots can travel from the lower extremities to the heart and lung area and cause life-threatening conditions such as cardiac or respiratory arrest. If a clot gets as far as the brain, stroke can occur that can permanently alter the patient’s movement and coordination.

Finally, the pain and swelling of a failing knee implant often requires time off of work and a long healing process. When the revision surgery is scheduled and undertaken, this too, takes time from which to heal. Additionally, the loss of income and cost of the surgery can be astronomical.

If you or a loved one was injured by a defective knee replacement, you may qualify for a free legal consultation.