The US Food and Drug Administration recently issued a class II recall for the Persona Trabecular Metal Tibial, a device used to assist patients experiencing knee problems. The manufacturer of the device, Zimmer, Inc. reports it is voluntary participating in the recall. The recall requests that all devices should be located and quarantined immediately. More than 11,600 devices are included in the recall.
The recall is in response to complaints that the device loosens, leading to serious injury and the need for revision surgery. Devices of all sizes and lots are affected. The notification was issued to distributors, hospitals, and surgeons, and recipients are asked to share the information with all staff and other affected individuals.
Class II recalls are used when products show potential to cause temporary or reversible adverse health problems, which is the case with the Zimmer implants. It should be noted the implants reportedly cause multiple complications, including radiolucent lines. Radiolucent lines are large gaps that development between components of the device or the device and the bone.
The gaps create a number of problems, including fluid buildup and wear-and-tear on the device that causes debris to form, loosen, and eventually break off. This can trigger a condition known as osteolysis, which is an early warning that an implant could eventually fail. Because some patients, including those who are older or overweight, tend to have more complications with implant devices, doctors are encouraged to be especially vigilant in watching for signs of osteolysis in these communities.
A loosened implant is also painful, and can trigger tissue and bone damage, as well as swelling in the affected area. In most cases, radiolucent lines trigger the need for revision surgery and a potential implant replacement.
Zimmer Familiar with Recalls
The company’s first recall was issued in 2008 for its Durom Cup hip component. Users of this device were suffering early failure because surgeons that placed the devices had not received sufficient training. There was also evidence the implant’s circular cutting surface on the edge of the device caused it to move out of place.
There was another official recall for Zimmer’s MIS Tibial components due to early loosening in 2010. The recall included nearly 70,000 devices. Four years later in 2014, an official recall was finally enacted for 40,000 of the NexGen devices because they contained defective screws.
Two of its most well-known products are the NexGen and High Flex Knee implant devices, which were marketed to patients looking for replacement devices that provided optimum flexibility in the knee. Both devices were reported to the FDA for problems with loosening and failure.
Zimmer Faces Legal Trouble
More than 1000 federal lawsuits were also filed against Zimmer in relation to its NexGen and High Flex Knees devices after patients suffered early failure and disability. Those trials are expected to begin later in 2015. A bellwether case is currently underway.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.