Medical device manufacturer Zimmer Biomet has voluntarily recalled a certain component of the Zimmer Persona total knee replacement system, after many patients reported a high number of device failure incidents.

The Zimmer total knee replacement recall only affects the device’s Persona Trabecular Metal Tibial Plate, after patients reported radiolucent lines and device failure.

The Zimmer Persona Trabecular Metal Tibial Plate is a metal component of certain Zimmer total knee replacement devices, which is meant to be implanted into the bone without the need for cement. The device attaches to the tibia using two pegs which are inserted into the bone and are supposed to simulate bone growth and natural stability.

Zimmer announced its recall of the Zimmer total knee replacement devices in February 2015, affecting nearly 12,000 knee replacement devices with Trabecular Metal.

Zimmer reportedly initiated the recall after numerous patients reported two significant problems attributing to device failure:

• Radiolucent lines: These lines or “gaps” that occur when excess intracellular fluid becomes trapped, along with metal debris from the metal knee component. These lines often indicate “poor seating” and potential device failure. Poor seating occurs when the knee replacement is not properly implanted, or some other factor causes it to move out of place. These lines are the first signs of device loosening.
• Device Failure: The affected Zimmer total knee replacement devices containing the Trabuclar Metal Plate have been reportedly detaching from their original implant sites and are “one of the most prevalent causes for revision in total knee arthroplasty” according to Zimmer.

If patients do not report these complications quickly, the surrounding bone tissue may wither and die. The FDA classified the Zimmer total knee replacement recall as a Class 2 recall, which are designated for drugs and medical devices documented to cause temporary or reversible injuries.

According to the FDA Zimmer total knee replacement recall, all sizes and lots of the Zimmer Persona Trabecular Metal tibial plate may be affected.

Overview of Zimmer Total Knee Replacement Problems

Patients who received Zimmer total knee replacement implants and suffered device failure, often experienced severe pain and inflammation that forced them to see their orthopedic doctors. Zimmer has drawn criticism for these knee recalls, as the company has undergone other device recalls in the past for serious patient injury reports.

The Zimmer Persona knee replacement was approved in 2012, through the FDA’s 510(k) program. Through this process, a medical device can quickly enter the market without undergoing rigorous pre market testing if they prove to work at an equivalent level with a similar device already on the market.

This program has been called into question before, with the Zimmer Persona knee replacements being one of the most recent additions to consumer complaints. Knee replacement surgeries are conducted to restore movement and knee stability to patients who have suffered from illness or injury that may have resulted in damage to the knee bone tissues.

In many cases of knee replacement failure, patients are forced to undergo revision surgery to remove or replace the failed knee implant.