If you have a Zimmer Persona knee implant, you might have a defective part that could cause part of the system to loosen.

In March 2015, Zimmer announced a voluntary recall of its Zimmer Persona Trabecular Metal (TM) Tibial Plate knee implant part. Zimmer said the recall affected 11,658 individual tibial plates.

According to the Food and Drug Administration, the Persona TM Tibial Plate recall affects all lots and sizes of a part that was uncemented, porous, coated and consisted of polymer and metal. Many of the parts were distributed to VA Medical Centers where they were implanted between 2012 and 2015.

The Class II designation means the FDA thinks the device can “cause temporary or medically reversible adverse health consequences.”

In X-rays, gaps can be seen between the Persona TM Tibial Plate and the shin bone where it was attached. These gaps can be indicative of “poor seating,” which leads to the conclusion that the tibial plate has slightly moved from where it was originally intended.

When that tibial plate moves, it fails to secure the implant. Patients may suffer from persistent pain, mobility problems, inflammation, an unstable knee or a tight knee that impedes movement.

Zimmer Persona Knee Implant Tibial Plate Problems

The Zimmer Persona TM Tibial Plate was designed to hold the components of the knee in place without the use of surgical cement. The plate includes two pegs that are designed to be inserted directly into the tibia, where the bone is supposed to grow around these pegs. Unfortunately, patients began reporting two main problems with the Persona TM Tibial Plate.

The gaps seen in X-rays are known as radiolucent lines, which are intervals measured in millimeters between the bone and cement of most knee implants. Because the Persona TM Tibial Plate is connected without cement, the radiolucent lines include the area between the bone and the plate.

The other noted problem is loosening of the Persona TM Tibial Plate from its originally intended position.

Zimmer appeared quite proud of the Zimmer Persona knee system when it was introduced at the American Academy of Orthopaedic Surgeons’ annual meeting in 2013.

According to Orthopedics This Week, Zimmer said at the time that the Persona “ushers in a new era in total knee replacement, combining personalized implants with intelligent instrumentation to provide surgeons with a new level of intraoperative precision to customize the best fit for their patients.”

The Arthritis Foundation says that knee replacements completed in this day and age should last 20 or more years after implantation. For patients to experience knee implant component failure just months later, or even a couple of years later, puts those patients at risk because they will most likely have to endure a revision surgery.

Knee revision surgery is often rough on patients who are more apt to suffer pain, infection, bone loss and damage to delicate nerves and blood vessels.

Patients who received the cementless Zimmer Persona TM Tibial Plate as a component in their total knee replacement surgery performed between 2012 and 2015 could have issues as a result of this defective part.