A component of the Zimmer Persona knee implant replacement system was voluntarily recalled  soon after it was introduced to the market.

The Zimmer Persona component recall was initiated by Zimmer Inc. in March 2015 due to severe adverse effects reported by patients. Problems with the Persona TM Tibial Plate included implant loosening and gaps developing between the bone and the knee implant — a sign of “poor seating.”

The following are some of the symptoms associated with a failing Zimmer Persona knee implant:

• Loss of Mobility
• Persistent pain
• Inflammation
• Knee instability
• Knee tightness

Those who have suffered from a failing Zimmer Persona knee implant between 2012 and 2015 that included the Persona TM tibial plate should be aware of the voluntary recall of this medical device.

Overview: Zimmer Persona Knee Implant

The Zimmer Persona Trabecular Metal Tibial Plate is part of the Zimmer knee replacement system. The device was manufactured to help give the knee added stability and mobility post implantation. The device becomes implanted into the bone attaching to the tibia. Two pegs that are part of the device grow into the bone post implantation.

There have been several reported complications linked to the Zimmer knee replacement system with a Persona TM tibial plate. Complaints of the device concern implant “loosening” and “radiolucent lines.”

Due to the number of adverse side effects that patients have reported, the device maker announced a voluntary recall of the component a mere three years after it was introduced. The number of devices affected by the recall reached nearly 12,000 devices.

The U.S. Food and Drug Administration (FDA) also announced Zimmer’s voluntary recall. The FDA categorized the recall as a “Class 2” recall, which pertains specifically to medications/medical devices that can cause reversible or temporary harm. During the Class 2 recall all lots and sizes were also affected.

According to Zimmer, almost 38 percent of patients who complained that their Zimmer Persona failed had symptomatic radiolucent lines or required revision surgery.

Radiolucent lines refer to gaps between the bone and knee component. These lines can be seen through x-rays. Radiolucent lines can also indicate signs of “poor seating,” which means and improperly positioned tibial plate.

Loosening occurs when the device essentially comes apart from its place of attachment. Loosening complaints, according to Zimmer, have been “one of the most prevalent causes for revision in total knee arthroplasty.”

Cited reasons for patients to have to undergo revision surgery have also included component failure, lack of ingrowth, persistent pain, globally tight knee, patella tracking issues, loss of fixation, and fracture.

Additionally, while revision surgery may provide patient relief and fix some resulting issues of the device it does come with its own set of complications. Revision surgery is often more dangerous than the initial surgery. Some risks may include leg length discrepancies, infection, blood vessel damage, pain and swelling, fractures, bone loss, and blood clots.