番茄社区

The FDA on Thursday that several Exactech joint replacement devices packaged in defective bags should be closely monitored for device wear or failure.

Many of the devices for knees, ankles, and hips -- which were manufactured by Exactech from 2004 to August 2021, and recalled in 2021 and 2022 -- were packaged in bags that were missing one of the oxygen barrier layers that protect devices from oxidation, which can degrade the plastic component before it's transplanted into the patient.

Proper packaging features multiple oxygen barrier layers to protect the device from air, the agency noted in their safety communication.

Oxidation of this polyethylene component may cause a slew of issues for patients, such as pain, bone loss, component fracture, device failure, premature device wear, or swelling of the area, all of which may result in the need for revisional surgery.

Exactech first recalled only certain hip replacement devices due to premature wear without a known cause. This was labeled as a Class II recall -- the second most serious grade indicates that the "product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote."

By February 2022, the manufacturer expanded a voluntary recall for certain knee replacements and total ankle replacements packaged in the defective bags, regardless of the device's label or shelf life. An estimated 80% of knee and ankle replacement devices manufactured since 2004 were packaged in defective bags.

Later that year, the company expanded its hip replacement device recall to include all hip devices with polyethylene components packaged in defective bags.

"The FDA is working with Exactech to assess whether any of its other joint implants that contain polyethylene components packaged in defective bags may result in increased oxidation and similar risks," the agency said.

The FDA recommended that no future implant surgeries be performed with any of the recalled knee, ankle, and hip devices. The agency also advised that healthcare providers monitor patients who have any of these implanted devices for possible wear, failure, and resulting bone loss. If there is a device failure suspected, providers should consider performing x-rays.

For patients who are experiencing pain, revisional surgery should be discussed on a case-by-case basis. That being said, it's currently not recommended that joint replacement devices be removed from patients who aren't having any new or worsening pain.

Patients are recommended to contact their healthcare providers about any pain, swelling, weakness, grinding, noise, or inability to bear weight on the device.

Exactech has set up an for recalled knee and ankle devices that are searchable by device serial number.

Comment