In February 2015, Zimmer Biomet announced a voluntary recall of its Persona knee replacement system due to a specific component of the device which was causing problems in some patients. In March 2015, the FDA announced the Class II recall of this component, called the Persona TM tibial plate.

A Class II recall is issued by the FDA in cases where a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” Class II recalls are not serious as Class I recalls, which indicate that the product may lead to severe injury or death.

The Zimmer knee recall affected approximately 12,000 implants distributed during the time period of March 2012 through March 2015. Patients who received this implant may suffer injuries as a result of an allegedly defective component in the knee replacement system.

Details of the Zimmer Knee Recall

Prior to the Zimmer knee recall, the device was hailed as a knee placement system offering an increased precision anatomical fit over competing devices. While this may have been true for some patients, other patients found that they experienced serious pain and complications as a result of the design of the product.

In particular, the Zimmer knee recall affects knee replacement systems that were implanted into the body without using cement. Instead of attaching the device with cement, the Zimmer Persona knee replacement system attaches to the knee using metal pegs that were designed to stabilize the implant.

For a number of patients, the use of metal pegs instead of the cement appeared to cause gaps between the bone and the knee implant, because the implant shifted from its original intended position. Also, some patients experienced loosening of the device.

Many patients affected by the Zimmer knee recall have had to have a second surgery to replace the Zimmer implant system. Revision surgery was recommended to patients who suffered chronic knee pain, loosening of the implants, unstable knee or tight knee. Other knee implant-specific issues such as loss of fixation, patellar tracking issues and lack of ingrowth were also reasons for patients to need a revision surgery.

Unfortunately for patients, a revision surgery is typically more difficult than an initial knee replacement surgery. The revision surgery targets problems with the initial surgery that may be more difficult to correct. Patients may find that they have more pain for a longer time, and increased recovery time and other issues in the revision surgery that were not present during the initial surgery.

Patients who had revision surgery whose device was subject to the Zimmer knee recall may also be at an increased risk for surgical site infections, fractures, blood clots, shortened bone length, and discrepancies in leg length after the revision surgery.

Were You Affected by the Zimmer Knee Recall?

If you had the Zimmer Persona knee implant system placed between 2012 and 2015, you may be eligible to receive legal compensation for your injuries.

An experienced attorney can review your case to help determine your eligibility to file a product liability lawsuit. Successful plaintiffs filing these kinds of lawsuits may be able to recover damages related to medical expenses, pain and suffering, lost wages and more. Consultations are free and can help get you headed in the right direction as you contemplate legal action.