Zimmer Inc., the manufacturer of the Zimmer Persona Trabecular Metal Tibial Plate, issued a voluntary Class II recall for about 11,700 of its products in March 2015.

The manufacturer had purportedly received six complaints for every 1,000 devices utilized. This is allegedly higher than what the manufacturers had initially expected.

Complaints surrounding the device pertained to loosening of the device and other adverse effects and complications that would need to be fixed by undergoing revision surgery.

Patients who had been implanted with a Persona knee replacement had also reported what are called radiolucent lines. These are dark lines that can be seen from X-ray images taken of the knee.

Radiolucent lines indicate other problems that are occurring with the tibial plate in the Persona knee replacement. Such complications include poor seating of the implanted device.

Zimmer Inc. distributed the Persona knee replacement device between Nov. 29, 2012 and Jan. 23, 2015. The company sold the device all through the United States, particularly within Veterans Affairs Medical Centers located throughout the country.

Sources say, however, that the Persona knee replacement device causes severe adverse complications and issues, including the need to undergo revision surgery. Some of the consumers who had been implanted with a Persona knee replacement suffered from the following: limited mobility; radiolucent lines; early failure for the device/implant; loosening of the implant; chronic pain; and revision surgery.

How does the Persona Knee Replacement Implant Work?

The Persona knee replacement tibial plateis inserted into the bones of the lower legwithout any cement. It is attached via two pegs which become implanted into a lower bone of the leg and the tibia bone. The purpose of the pegs is to give the Persona knee replacement additional support and stability. The pegs, after implantation, are meant to grow into the bone while simultaneously allowing for this function.

Recall of the Persona Knee Replacement Tibial Plate

Thousands of patients were affected when the U.S. Food and Drug Administration announced the recall of the Zimmer Persona Trabecular Metal Tibial Plate, part of the Persona knee replacement. The company had recalled the implant device due to complaints it had received from consumers regarding adverse effects and complications from the device.

All sizes and lots of the device were recalled. The recall announced by the FDA affected more than 12,000 Persona knee replacement implant systems. The announcement made by the FDA in March 2015 stated, “Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution.”

The recall announced was categorized as a Class II recall. Such a recall is described as one not life-threatening but that can cause adverse effects and reparable damage.

Besides the radiolucent lines and poor seating cited in the recall, other reported adverse effects have included loss of fixation, fracture, instability, lack of ingrowth, and persistent pain.