Weitz & Luxenberg is now investigating cases in which patients suffered harm from use of a Zimmer Persona knee replacement device.
The porous coated, uncemented Zimmer Persona Trabecular Metal Tibial Plate was voluntarily recalled on Feb. 16 and was categorized as a U.S. Food and Drug Administration (FDA) Class II recall on March 12.
The porous coated, uncemented Zimmer Persona Trabecular Metal Tibial Plate recall came in response to growing complaints of loosening of the device and the presence of radiolucent lines evident upon postoperative X-rays. A review of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database reveals that these problems appear to have forced several patients to undergo costly and painful revision surgeries.
Healthcare providers have reported to the FDA instances of patients having early failure with the Zimmer Persona. “This is especially distressing since the device has only been available for a few years,” said David L. Rosenband, an associate attorney on the W&L Defective Drugs and Devices team, which has successfully battled knee- and hip-replacement device makers in the courts for many years.
It is not the Zimmer Persona device as a whole that the company recalled, but a key component — its porous coated, uncemented Trabecular Metal Tibial unit.
FDA Notification of Porous Coated, Uncemented Zimmer Persona Trabecular Metal Tibial Plate Recall
A Class II recall is the FDA’s second-most serious category of market-withdrawal actions. The federal agency issues a Class II recall when there is no immediate risk of death or serious injury from a product, but the product nonetheless possesses the potential to cause great harm.
The FDA said the Class II recall involving the Zimmer Persona Knee affects sizes C through J of that product’s porous coated, uncemented Trabecular Metal Tibial component, both the right- and left-knee versions.
According to the FDA, there are 11,658 porous coated, uncemented Zimmer Persona Trabecular Metal Tibial Plates in worldwide distribution.
In the U.S., these patients hail from half the states, including New York, New Jersey, and California — jurisdictions in which W&L has offices — as well as Pennsylvania, where many of W&L attorneys are admitted to practice.
Zimmer Persona Approved via 510 (k) Process
Zimmer obtained FDA approval to market Persona throughout the U.S. in 2012 on a 510(k) “fast-track” process.
In a 510(k) approval process, compared to the more rigorous pre-market approval (PMA) process, the device maker needn’t perform lengthy and costly pre-market clinical testing of the product if it is substantially similar to another FDA-approved product that previously did undergo extensive clinical testing.
You May Deserve Compensation
Manufacturers have a responsibility to the consumers who use their products. They need to be safe and effective. This is especially true when dealing with a medical device implanted into a human body.
When the products aren’t safe and cause damage, those people who have been harmed may deserve to be compensated.
Zimmer Persona patients can contact W&L to discuss their legal rights to compensation from Zimmer for the harms done to them.