Zimmer Knee Cases
Zimmer Persona Knee FDA Recall for Zimmer’s Persona Trabecular Metal Tibial Plate knee implant.
The FDA announced a Class II recall for Zimmer’s Persona Trabecular Metal Tibial Plate knee implant. The recall affects all lots and sizes of the knee implant, affecting all 11,658 devices that were recalled, according to the FDA’s website. Also, according to an announcement made by the FDA, they said Zimmer Inc. initiated a voluntary recall of their Persona Trabecular Metal Tibial after there was an increase in complaints of loosening and radiolucent lines. All sizes and lots of the affected devices will be removed from the market and will no longer be distributed.
A Class II Recall occurs when a product can “cause temporary or medically reversible adverse health consequences.” Patients who have been implanted with the Persona Trabecular Metal Tibial Plate face the risk of their tibial component loosening. Indications of this complication include radiolucent lines on imaging tests, and such loosening may cause pain and issues with mobility, often requiring the patient to have an additional surgery.
Possible side effects include:
- Joint fluid
- Tissue damage
- Osteolysis Severe pain
- Swelling Bone damage
Zimmer NexGen Knee FDA Recalls Issued to Zimmer Inc.
An FDA Class II recall typically indicates that a device may cause “temporary or medically reversible” health problems, as well as a remote possibility of serious health problems.
In addition to the FDA Class II recall, a voluntary recall was made by Zimmer Inc., regarding the NexGen MIS Tibial Component, because according to drug watch, “one of the pieces could loosen or fail because of shoddy manufacturing.” The voluntary recall that was initiated affects 41,180 devices and includes eight sizes (1-8).
The devices were meant to increase range of motion and imitate natural knee function, but plaintiffs who have filed cases against Zimmer Inc. claim that the devices actually caused a range of complications listed below:
- Decreased range of motion
- Extreme pain
- Tissue and/or nerve damage
- Bone degradation or fractures
- Instability
- Infection
- Blood clots
- Ultimate failure of device implant.
Also, among those who have filed lawsuits, painful revision surgery was often required. The NexGen Flex devices have been implanted in approximately 150K patients.
First Zimmer NexGen Knee Bellwether Trial Approaching
Federal lawsuits have been consolidated into multidistrict litigation (MDL) in the U.S. District Court in the North District of Illinois, with the first bellwether trial set to begin in 2015.
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