While Levin Simes Abrams is not currently investigating Zimmer Persona recalls at this time, we hope you find the information below informative.
The FDA has recalled all Zimmer Personal Knee C-J Tibial plates used in Zimmer Persona Total Knee Replacement implant surgeries, manufactured and distributed between November 29, 2012 and January 23, 2015.
If you received one of these Zimmer Persona devices as a knee replacement, you could experience or may have already experienced aseptic loosening of the joints, radiolucent lines on exam in the knee, premature failure of the knee replacement, pain, difficulty walking or bending of the knee, or additional surgeries to correct or remove the Zimmer Persona knee.
The Zimmer Persona design is a failure resulting in unnecessary complications, risks, pain, and revision surgeries, all of which can result in additional post surgery complications and lowered quality of life.
On March 12, 2015, the Federal Drug Administration (FDA) issued a Class II recall of the Zimmer Persona Trabecular Metal Tibial Plate. The recall covers 11,658 devices shipped worldwide and throughout the United States. While the official reason for the recall was “an increase in complaints of loosening and radiolucent lines”, the reason for the recall is simple: Zimmer was no longer able to ignore increasing complaints and notices of Zimmer Persona injuries after implant, where the devices loosened despite no infection or surgical complications or errors. Patients with the Zimmer Persona observed radiolucent lines in their knees on exam, experienced pain or failure of the device at early rates. Such rates predict a large amount of devices will fail over their normal lifespan. The result is Zimmer recalled nearly 12,000 of their Zimmer Personal tibial plates of all lots and all sizes from C-J.
Those implanted with the recalled Zimmer Personal Total Knee Replacement may be suffering from:
Zimmer released a letter to hospitals on March 03, 2015 outlining the recall of all sizes of their Zimmer Persona Trabecular Metal Tibial Plates. Zimmer states that they expect the risks to include:
These are the immediate (pain) and long term (revision surgery) health consequences that may result from having been implanted with the Zimmer Persona recalled total knee replacement.
The affected products include:
The Zimmer Personal recall is not the first knee recall by Zimmer to result in lawsuits for those injured by their devices. Zimmer recalled 40,000 NexGen total knee replacement plates last year due to the possibility these plates could also loosen and fail. The resulting loosening and failure can create complications such as:
As seen in this New York Times article, Senator Charles E. Grassley, on behalf of the United States Senate Committee on Finance, issued a strongly worded letter to Zimmer asking for more information regarding payments they made to doctors for their hip and knee devices.
In the letter the U.S. Senator states:
“I was troubled by last month’s New York Times account of Zimmer’s response to the allegations of safety concerns raised by two of its consultants. Specifically, The New York Times reported that one of the surgeons with whom Zimmer had a financial relationship, Dr. Richard Berger, raised concerns to the company a few years ago about the premature failure of a Zimmer knee, the NexGen CR-Flex.1 According to the article, Dr. Berger was a long-time consultant for Zimmer—a financial relationship that spanned more a decade—with Dr. Berger receiving more than $8 million during that time frame. The New York Times also reported that a second Zimmer consultant, Dr. Lawrence Dorr, alerted other doctors that Zimmer’s Durom hip device was failing a few years after they were implanted in patients. According to The New York Times, the two doctors were not alone in their concerns about the device failures. In both cases, however, Zimmer responded that it was the surgeons’ technique, not the devices that were flawed.”
The United States Senator from Iowa goes on to request information regarding:
Zimmer Holdings, and their company Biomet (which has previously faced bribery charges) have a long history of putting profits ahead of patients.
All Zimmer Personal Knee Tibial plates used in Zimmer Persona Total Knee Replacement surgeries and that were manufactured and distributed between November 2012 and January 2015 have been recalled by the FDA. If you received a Zimmer device, you could suffer from aseptic loosening of the joint, premature device failure, and additional revision surgeries or complications due to the design defects in the Zimmer Persona device.
While Levin Simes Abrams is not investigating new cases against Zimmer, ongoing litigation against Zimmer is continuing for cases with these facts:
Persona devices on the market before October 2012 and after May 2015 are not subject to the recall.