Zimmer Holdings Inc. has recalled 11, 658 parts used in its Persona Trabecular Metal Tibial Plate/Persona TM Tibia knee implant systems.
According to the Food and Drug Administration (FDA), Zimmer is initiating the voluntary global recall following an increase in complaints of “radiolucent lines and loosening.” All sizes and lots of the affected devices are being removed from distribution. In the U.S., the part was distributed to a number of VA Medical Centers in states including South Dakota, Georgia, Alabama, Massachusetts, New York, Ohio, Indiana, Pennsylvania, Missouri and California.
It’s a Class II recall, which means the FDA believes the product can “cause temporary or medically reversible adverse health consequences.”
Problems associated with this implant can cause serious complications and patients can face the risk of loosening of their tibial component. Indications of loosening include radiolucent lines on imaging tests, which are large gaps between the device and bone. Loosening can cause pain and significant mobility problems, and can require the patient to undergo additional surgery to remove and replace the loose tibial component.
Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on February 16, 2015 via mail. Customers were asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately. The Inventory Return Certification Form should be completed and returned along with the recalled product. Customers may contact the following with any questions: 1-877-946-2761 between 8:00 am and 5:00pm EST.
The FDA Notice can be read here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=133978
Introduced in 2013
Zimmer introduced, “Persona – The Personalized Knee System”, at the 2013 American Academy of Orthopaedic Surgeons annual meeting. The company said the new system “ushers in a new era in total knee replacement, combining personalized implants with intelligent instrumentation to provide surgeons with a new level of intraoperative precision to customize the best fit for their patients.
I had to have a knee replacement in October 2017 because the Zimmer Persona loosened. I went 3 years in severe pain as the doctor thought my back was causing the problem. The attorney I went to said my lot number was not recalled. Nothing else I can do?
How do I receive the code number of my knee replacement ? I have had much pain since 2017
I also had a persona knee replacement on June 16,2016 And less than 3 years later it’s loose and I need revision surgery. Cant believe zimmer is not responsible for this.
My knee replacement was in February of 2021, my knee never healed, and I suffered two years of my life because of a failed Zimmer Persona knee prosthetic. I can’t find an attorney to take my case. My new replacement is great, one month after revision surgery I can walk normally again.