If you underwent knee replacement surgery between 2012 and 2015, your hardware might contain a recalled component, the Persona TM Tibial Plate.

Zimmer (now Zimmer Biomet) issued a voluntary recall of the Persona Trabecular Metal (TM) Tibial Plate in January 2015 after reports of device loosening.

X-rays of the affected knee implants showed gaps between the knee implant part and the bone where it was attached, indicating possibly “poor seating,” which means the implant component moved from its originally intended place.

Patients suffering from a variety of issues might be showing signs that the Persona TM Tibial Plate has failed to secure the implant. Constant pain, mobility issues, inflammation, knee instability, or a feeling of knee tightness are all possible side effects.

Reasons for Persona TM Tibial Plate Problems

The Persona TM Tibial Plate covered under the recall is a metal component that anchors the implant to the bone without the use of surgical cement. The plate is made with two long pegs that are designed to be inserted directly into the tibial bone. Over time, the bone is supposed to grow in and around the pegs to fully secure the knee implant components.

Unfortunately, patients began to complain of two main issues with the Persona TM Tibial Plate:

1. Radiolucent Lines: Patients underwent x-rays that indicated small gaps between the tibial plate and the bone, possibly indicating “poor seating.” Radiolucent means the evidence is visible on an x-ray. Radiolucent lines are intervals usually between the bone and cement, an area measured in millimeters. Because the Persona TM Tibial Plate is not anchored with any surgical cement, the radiolucent lines are defined as the area between the bone and the plate.
2. Loosening: The uncemented Persona TM Tibial Plate became loose from its originally intended position. Zimmer has said that loosened components are the most prevalent reason for knee implant revision surgeries.

Zimmer’s voluntary recall began in January 2015, and the FDA announced it as a Class 2 Recall in March 2015. The FDA indicates Class 2 Recalls are used for medications and medical devices that can cause temporary harm or problems that can be reversed. The FDA said all sizes and lot numbers of the Persona TM Tibial Plate that was not anchored by cement were covered under the recall.

According to Zimmer, 38 percent of patients who complained of the Persona TM Tibial Plate either had radiolucent lines that were causing problems or had undergone revision surgery to correct the issues.

In addition to experiencing pain, mobility issues, inflammation, knee instability, or a tight knee, patients complained of patella tracking issues, fractures, and loss of fixation of the knee implant.

While any invasive surgery comes with risks, patients undergoing another knee replacement operation might be at a higher risk of complications. With repeat surgery, the knee can become swollen and painful, infected, suffer bone loss or incur damage to nearby nerves and blood vessels.