In February 2015, Zimmer Biomet announced a voluntary recall of the Zimmer Persona Trabecular Metal Tibial Plate over reports of knee replacement complications.

Reports allegedly indicated that the Zimmer total knee replacement implant was loosening from where it had been implanted, and further MRI or X-ray reports had showed that gaps have occurred between the implant and bone. This was allegedly shown to be a sign of “poor seating.”

Accordingly, indications of “poor seating” or a malfunctioning Zimmer total knee replacement includes the following symptoms: knee instability, inflammation, loss of mobility, knee tightness, and persistent pain.

The Zimmer total knee replacement is called the Zimmer Persona Trabecular Metal tibial plate. It is made up of a metal component that is inserted into the bone but without any cement. The Zimmer total knee replacement is inserted and becomes attached to the tibia.

The medical device has two pegs that when inserted become attached to the bone. The pegs are then supposed to “grow” or develop into the bone. The insertion of these pegs give greater stability to the Zimmer total knee replacement implant.

The recall that resulted was announced voluntarily by the medical device’s manufacture, Zimmer Biomet, in February 2015, affecting almost 12,000 implant components.

The recall occurred after Zimmer allegedly received grievances of two issues that patients had had with the Zimmer total knee replacement. One complaint was due to radiolucent lines, while the other was mainly a result of loosening issues that were occurring.

Complaints due to radiolucent lines had indicated that spaces or gaps, visible on X-rays, had appeared between the bone and the Zimmer total knee replacement. Allegedly an indication of “poor seating,” radiolucent lines occur when the replacement implant repositions from its intended location. Radiolucent lines, therefore, are indications for when the implant starts to loosen up.

The second complaint was the loosening of the trabecular metal plate. It allegedly loosens from where it was originally placed and attached. According to Zimmer Biomet, loose components, “is one of the most prevalent causes for revision in total knee arthroplasty.”

Although Zimmer had issued a voluntary recall of its Zimmer total knee replacement, the U.S. Food and Drug Administration followed that recall by initiating and announcing its own. The federal agency announced its own recall in March 2015. The recall was determined a Class II recall, which categorizes any such drug or medical device deemed to be one to cause “temporary or reversible harm.”

The federal agency had also reported that the recall included all types and sizes of the Zimmer total knee replacement medical device.

According to Zimmer Biomet, 38% of patients reporting implant failures had evidence o radiolucent lines or had to undergo revision surgery due to its malfunctioned Zimmer total knee replacement.

Symptoms of a possible need for revision surgery to repair the Zimmer total knee replacement includes and is not limited to instability, fracture, loss of fixation, lack of ingrowth, persistent pain, loosening of device, component failure, globally tight knee, and patella tracking issues.

And while revision surgery does repair some of the issues resulting from a malfunctioned Zimmer total knee replacement, it does come with its own complications and sets of additional risks. These risks also include and are not limited to infection, blood clots, bone loss, leg length discrepancies, fractures, pain and swelling, and nerve/tissue blood vessel damage.