There have been many reports of loosening and other failure problems with the Zimmer Persona artificial knee replacements.
FDA Warning and Class 2 Recall
The FDA on March 12 announced a Zimmer Persona knee recall, involving all lots and sizes of the Persona Trabecular Metal Tibial Plate used during knee replacement procedures throughout the United States between November 2012 and early 2015.
Zimmer sent an Urgent Medical Device Recall notice in late February, warning surgeons and hospitals about an increase in complaints involving radiolucent lines and loosening among patients who received a Zimmer Persona knee.
Recently, the FDA categorized this action as a Class 2 recall. According to Zimmer, the current complaint rate is higher than similar artificial knee devices, and noted that six out of every 1,000 implants may fail. But according to some medical experts, the risk of Zimmer Persona knee failure may be much higher with time.
What is the Zimmer Persona Knee?
The Zimmer Persona knee replacement system was introduced in late 2012, marketed by Zimmer as having “[a]natomically accurate components available for a new level of fit tailored to each patient’s unique anatomy.”
The “Personalized Knee” system was designed to provide a high degree of accuracy in it’s fit. But, the Zimmer knee faulty design increases the risk of loosening, pain and ultimately failure, leading to re-do knee revision surgery.
According to Zimmer, patients may note problems with initial fixation, causing knee pain and discomfort. This leads to complications where the knee replacement never achieves correct fixation, and some patients may require additional knee replacements or removal of the artificial knee device.
Zimmer Notification Letter to Hospitals
Zimmer notified hospitals recently that, “Out of the complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, 28% identified asymptomatic radiolucencies, 8% subsided, and 28% were inconclusive. Aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty and a number of factors may contribute to the loosening failure mode, including patient characteristics, rehabilitation protocol and compliance, surgical technique, and product features.”
Zimmer Persona Nationwide Recall
The recall affects all lots and sizes C-J, both left and right, of the Persona Trabecular Metal Tibial Plate. According to the FDA, about 11,658 units are affected by the recall.
Surgeons and hospitals have been made aware of the problem, and all of the recalled Zimmer Persona knee implants have been returned to the manufacturer. It is unclear whether patients with a defective Zimmer Persona knee have been notified of the recall or provided instructions about the need for further medical monitoring.
Zimmer Persona Knee Lawsuits
Zimmer Persona knee lawsuits are being filed against the manufacturer, alleging that the company failed to adequately research and test the design before aggressively marketing the Persona Knee system to doctors throughout the United States.