Zimmer Persona System Recall Explained

Zimmer Persona Recall

In February 2015, Zimmer stopped shipping the Zimmer Persona Personalized Knee System’s Trabecular Metal Tibial Plate and voluntarily withdrew it from the market. By March 2015, the FDA had categorized the recall as a Class II. Zimmer began the recall after several reported events were submitted to the FDA such as the device loosening or lines in the X-ray film. Radiolucent lines are dark lines that are seen on an X-ray of the knee. The lines indicate poor fixation and are usually associated with premature failure of the device.

Recall Timeline

January 23, 2015– Zimmer Persona Knee was removed from the market.

February 16, 2015– FDA sent an “Urgent Medical Device Recall” notice to surgeons and hospitals.

March 12, 2015– FDA categorized Zimmer Persona Knee recall as “Class II Recall.”

Zimmer Persona Knee Reviews

Studies have shown that 15%-39% of patients who undergo total knee surgery are not satisfied with the outcome. The Zimmer Persona Knee System is no different. Here are some reviews of the Zimmer Persona Knee replacement.

I have it in my right knee an it’s swollen larger than a basketball. It hurts when going up an down stairs and on cloudy days is not good at all for me.

Don’t do it! Almost 2 years and 2 surgeries and I still can’t walk.

Mine has not been right. It crackles and is real swollen. Hurts all the time.

Zimmer Persona Femoral Component

The Persona Femoral Component was the second Zimmer knee device to be recalled. Marketed for use in female patients, Zimmer claims it provides a superior fit and more stability. One of the biggest reports against the Femoral Component was its tendency to loosen, or as the FDA stated “collapsing” of the component which requires revision surgery. The Femoral Component was recalled by the FDA because several of the implants did not fit together properly once inserted.

Zimmer Persona Articular Surface

The Persona Articular Surface was also recalled by the FDA due to a complaint rate of nearly .82% since the product was introduced. Zimmer launched the Persona Knee System in 2012, and since then they have received several reports of fractures after the implantation of the Tibial Articular Surface Provisional device. Based on these reports, an official FDA investigation, Zimmer determined that updates were needed for the labeling of the device.

Zimmer Persona Knee Problems

There have been several reports of problems with the Zimmer Persona Knee Replacement,. When the company altered the original NexGen design and created the NexGen Flex, it was not required to test the new, and supposedly improved, version before releasing them for consumer use. Without studies or clinical trials, patients who had an implant were given an untested device.

The FDA received hundreds of reports of complications from the Zimmer Knee devices. Some of these problems included:

  • Severe knee pain
  • Device failure
  • Swelling
  • Loosening of knee component
  • Poor range of motion

Zimmer Persona Knee System

On March 12, 2015 the FDA announced a Class II Recall of nearly 11,000 Zimmer Persona Knee implant parts because of premature loosening and radiolucent lines. The Persona Knee System was marketed as “The Personalized Knee System” by Zimmer Inc. and since its launch, the company has been linked to several failures and complications from patients all over the U.S. The recall relates to all of the following systems:

Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.

This lawsuit is for patients who had a Zimmer Persona knee replacement. If you, or a loved one, had this device implanted and have had complications, contact Hood National Law Group today. 

Contact us today at 1-800-214-1010.

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