The Zimmer Company, based out of Warsaw, Ind., announced a Zimmer Persona recall of its cementless trabecular metal tibial plate in February 2015. This voluntary recall was followed shortly afterward by an announcement by the FDA.

The U.S. Food and Drug Administration announced the Class 2 Zimmer Persona recall in March 2015. A Class 2 recall is reserved for medical devices and pharmaceutical remedies that can cause harm but whose harm might be reversible.

The trabecular metal tibial plate is a component of a total prosthetic knee used in a total knee arthroscopy. The trabecular metal tibial plate is a flat metal plate with two metal pegs on the bottom. The metal plate sits on top of the tibia, the largest bone of the lower human leg.

The pegs are inserted into the bone during a knee replacement surgery and are not adhered using any cement or glue products whatsoever. The manufacturers of the component were reliant upon the bone to grow around the pegs to stabilize the plate over time.

The Zimmer Persona recall as initiated by the company and then by the FDA was done because of complaints received from recipients and their physicians leading to the necessity of a total knee revision, a secondary surgery in which the old prosthetic is removed and a different unit is implanted due to problems. The complaints centered around two main issues with the trabecular metal tibial plates.

Zimmer Persona Recall Due to X-Ray Findings

When patients experienced problems with their Zimmer prosthetic knees, they often presented themselves to their orthopedic physicians and X-rays were taken.

Often, X-rays revealed what is referred to as radiolucent lines. These are gaps between the bone and the plate indicating that the plate was not situated well or likely that the pegs were growing into the bone as expected for stability.

The radiolucent lines, according to the Zimmer Company, are the first signs that a prosthetic component is becoming loose and failing. They are the best predictor of an upcoming need for a knee revision surgery.

Knee revision surgery exposes a patient to all kinds of additional risks. Hospitals themselves are huge sources of infections. Secondly, an additional surgery can cause blood clots, bone and tissue loss, and resultant differences in leg length. These are all liabilities that a prosthetic company would want to avoid.

What are the Signs that a Trabecular Metal Tibial Plate is Failing?

Among recipients of the trabecular metal tibial plate, there were common complaints leading up to the need for a knee revision surgery. Some of those complaints were:

• Swelling of the knee
• A feeling of tightness in the joint
• Continual pain in the area
• Fracture
• A feeling of instability, like the knee might buckle when ambulating
• A lack of mobility altogether, inability to walk

The Zimmer Persona Recall affects 12,000 units domestically alone. Some of those were not implanted, just distributed. Of those implanted, many may be suffering, unaware of this recall.

If you think you or a loved one have been hurt by the implantation of this product, you may qualify for a free consultation with a knowledgeable medical device attorney.