A Zimmer Persona recall for knee implant components numbering in the thousands has been issued because of reports of loosening and radiolucent lines.

Many people need knee arthroplasty surgery due to a number of different reasons. These include rheumatoid arthritis or osteoarthritis, collagen disorders, loss of joint configuration following a trauma, flexion deformities and instability and failed surgical attempts to save a knee.

Zimmer Biomet, based in Northern Indiana, is one of the world’s leading makers of artificial joints. It designs, manufactures, sells and distributes the Zimmer Persona Trabecular Metal Implant. It is also at the center of a voluntary Zimmer Persona recall by the manufacturing company.

What is a Zimmer Persona Knee Implant?

The Zimmer Persona knee implant has a tibial plate feature that is a metal piece implanted to the bone without using cement. It has two pegs, to give the implant stability, that are inserted into the bone with the intention that the bone and the tibial plate will grow together.

However, there have been growing reports of two major issues with the Zimmer Persona Knee Implant: radiolucent lines and premature loosening. These reports have led to a Zimmer Persona recall.

One of the major issues with the Zimmer Persona Trabecular Metal Plate is radiolucent lines. Radiolucent lines show up on x-rays. They look like gaps between the knee implant and the bone which is a sign that the implant has moved from where it should be. Radiolucent lines are the first sign of loosening.

No medical device is perfect, but Zimmer Persona knee implant patients have reported premature loosening of the device. Loosening occurs when the knee implant comes apart from the bone and is not where it was attached during surgery.

When loosening occurs with a knee implant, soft tissue can grow between components and the bone where bone tissue should be growing. This can create pain and joint instability.

After a long time with any knee replacement, loosening is expected. But Zimmer Persona patients are experiencing loosening complications after just a couple years.

Revision surgery often becomes necessity for patients with loosened knee implants. Revision surgery, however, is far more dangerous than the original knee replacement surgery, is fraught with more complications and has a longer recovery time.

Zimmer Persona FDA Recall

In March 2015, Zimmer voluntarily recalled well over 11,000 Persona knee implants because of the reports of loosening and radiolucent lines.

Quickly following this, the U.S. Food and Drug Administration announced a Class II Zimmer Persona FDA recall. A Class II recall is reserved for medical devices that can cause temporary or reversible negative health consequences.

The FDA said, “Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial Plate following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution.”

The voluntary Zimmer Persona FDA recall has affected thousands of knee implant patients. Many patients have had to undergo costly and painful revision surgery. This may cause loss of income and high medical bills for revision surgery patients.

If you or someone you love has been implanted with a knee implant affected by the voluntary Zimmer Persona FDA recall, you may be entitled to legal compensation.