With just less than three years on the market after the product’s introduction, the makers of the Zimmer knee replacement system, Zimmer Inc. issued a voluntary recall of its Persona Trabecular Metal Tibial Plate. The recall was initiated in March 2015 and resulted because of severe adverse effects and injuries patients were experiencing with the device.

Some of these adverse effects are the result of loosening around the implant’s positioning and radiolucent lines that occur because of gaps between the bone and tibial plate component.

There are several symptoms that may indicate a faulty Zimmer knee replacement system. Some of these signs include the loss of mobility, knee tightness, knee instability, inflammation, and persistent pain. Any gaps shown between the knee implant and bone also indicates a sign of “poor seating.”

Zimmer Knee Replacement System

The Zimmer Persona Trabecular Metal Tibial plate is part of the Zimmer knee replacement system. The device becomes implanted into the bone and attaches to the tibia. Parts of the tibial plate include two pegs that essentially grow into the bone after implantation. The two pegs provide the knee implant greater stability and mobility.

However, a voluntary recall was announced by Zimmer because of the number of complaints they received from patients who had been implanted with the device. Complaints surrounding the Zimmer knee replacement system includes “radiolucent lines” and “loosening” of the device. More than 12,000 tibial plate components were affected by the recall of the Zimmer knee replacement system.

The issue with “loosening” of the device stems from the device essentially coming apart from its place of attachment. According to Zimmer, loosening complaints have been “one of the most prevalent causes for revision in total knee arthroplasty.”

Radiolucent lines are the second issue revolving around the Zimmer Tibial plate. Radiolucent lines occur because of gaps between the bone and knee component that can be seen through x-rays. Radiolucent lines indicate signs of “poor seating” for which the Tibial plate is improperly positioned.

The U.S. Food and Drug Administration (FDA) announced Ziimmer’s voluntary recall of the Zimmer knee replacement system. The recall was categorized as a “Class 2 Recall” which denotes medical devices and medications which can cause temporary or reversible harm. All sizes and lots were affected during the recall.

Some cited reasons for patients to undergo revision surgery have included: component failure, loosening of the device, lack of ingrowth, persistent pain, globally tight knee, patella tracking issues, loss of fixation, and fracture.

Although revision surgery does provide relief and can fix issues resulting from a defective tibial plate, revision surgery does come with its own set of complications. Some of these risks can even be more serious than the initial surgery. Some of these risks include the following: leg length discrepancies, infection, blood vessel damage, pain and swelling, fractures, bone loss, and blood clots.