According to reports, Zimmer, the manufacturer of the Persona knee replacement system, has voluntarily issued a recall of one of the components of the medical device after patients started suffering from adverse effects and complications.

The Persona knee replacement recall , which only affects a component called the “Persona TM Tibial Plate,” was announced in February 2015. This was after the device was first introduced to the market in 2012. Later, after the manufacturers announced the Persona knee replacement recall, the U.S. Food and Drug Administration also announced the recall shortly thereafter as a Class II recall.

The FDA defines a Class II Recall as, “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The report emphasizes that although the recall for such medical devices is not as serious as to cause death, there is the possibility that the medical device could cause serious damage due to the recall of the medical device.

Allegedly, more than 12,000 patients were implanted with the Persona knee replacement system between March 2012 and March 2015.

Persona Knee Replacement Recall Details

Reports claim that the Zimmer Persona medical device was a knee replacement that had allegedly offered a more precise anatomical fit in comparison to other knee replacement products.

The recalled tibial plate is designed to be implanted in the lower half of the knee without the use of cement. Without the use of cement, the medical device instead uses two metal pegs which attach to the knee and help stabilize the replacement device.

According to adverse event reports, gaps can develop between the bone and the knee implant when the device shifts from the position that it was originally implanted in. Reports indicate that loosening of the medical device had also occurred.

As a result of the experienced failure, including loosening of the medical device and gaps that have occurred, several patients have needed to undergo revision surgery to fix the issues.

An increased likelihood of requiring revision surgery may also occur with the following symptoms and issues including but not limited to: knee pain, a tight or unstable knee, device loosening, and issues such as lack of ingrowth with the knee, patellar tracking issues, and loss of fixation.

Additionally, although revision surgery is able to reverse several issues resulting from the Persona knee replacement system, not all issues may be helped with revision surgery. Revision surgery also comes with its own set of complications and adverse effects as well. Reports indicate that revision surgeries may cause a higher risk of complication than that of the initial surgery.

Some complications and adverse effects that may result from undergoing revision surgery include, but are not limited to the following: swelling, infections in the surgical site, pain, blood clots, bone loss, and fractures.