An FDA safety communication issued Thursday serves as a reminder that medical device packaging plays a critical role in the lifecycle of the device itself.
All Exactech joint replacement devices (including knees, ankles, and hips) contain a plastic component which should be in packaging that contains multiple oxygen barrier layers as indicated in the package specification, FDA said in the March 23 notice. However, some of these devices manufactured between 2004 and August 2021 were in medical device packaging bags that were missing one of the oxygen barrier layers that protect devices from oxidation, a chemical reaction with oxygen that can degrade plastics over time.
Oxidation can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery. The devices were recalled in 2021 and 2022, but FDA sent out the communication this week to remind healthcare providers not to implant any knee, ankle, or hip devices recalled by Exactech. The agency stopped short of recommending removal of well-functioning Exactech devices from patients who do not have any new or worsening pain or symptoms.
Exactech devices with defective medical device packaging
- Hip replacement devices
In June 2021, Exactech recalled some GXL Liners for Novation, Acumatch, and MCS hip replacement devices due to excessive and premature wear, but the root cause was unknown. FDA classified these as a class II recall in July 2021. In August 2022, Exactech expanded the hip replacement device recall to include all hip devices with polyethylene components in defective medical device packaging. FDA classified these as a class II recall in September 2022. - Knee and ankle replacement devices
In February 2022, Exactech expanded a voluntary recall on all Optetrak, Logic, and Truliant knee replacements and Vantage total ankle replacements in defective medical device packaging regardless of a device’s label or shelf life. Exactech recalled the devices because around 80% of the knee and ankle replacement devices manufactured since 2004 were packaged in defective bags. On April 7, 2022, the Gainesville, FL-based company issued an updated urgent medical device correction notice with additional identified devices advising surgeons, hospitals, and healthcare providers to avoid implanting devices that were packaged in defective bags. Devices in defective bags were possibly implanted through Feb. 7, 2022, FDA noted. The agency classified these as a class II recall in October 2022.
FDA said it 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.
Recommendations for patients with an implanted Exactech device
- If your knee, ankle, or hip replacement device is functioning well and you have no pain or symptoms, FDA does not recommend surgery to remove the device.
- FDA recommends patients contact their healthcare provider if they have any Exactech joint replacement device implanted and have any new or worsening pain or swelling, inability to bear weight, grinding or other noise, or weakness around the implanted device.
- Exactech has an online database where patients with knee and ankle devices can search to see if their implant is a part of the recall. Patients will need their device serial number to run the search.
Recommendations for healthcare providers
- Do not implant any knee, ankle, and hip devices recalled by Exactech.
- Based on currently available information, FDA does not recommend removal of well-functioning Exactech joint replacement devices from patients who do not have any new or worsening pain or symptoms.
- Monitor patients who have any implanted devices manufactured by Exactech between 2004 and August 2021 for potential device wear, failure, or bone loss. Consider performing X-rays to further evaluate a patient and their implanted device if you suspect a failed device.
- Discuss revision surgery with patients who may have worsening pain or joint weakness that is potentially attributable to the device based on clinical exam, on a case-by-case basis. As a part of shared decision-making, healthcare providers are urged to discuss the benefits and risks of all relevant treatment options with patients.
- Remove all recalled devices from inventory and return to Exactech.
- Medical professionals should visit the Exactech recall website for more information about the recalled knee, ankle, and hip devices and resources.
Also, in August 2021, Exactech expanded its Truliant total knee system with a new porous-coated implant option (pictured below). The Truliant porous knee came as welcome news to surgeons interested in a non-cemented approach. The company said the porous-coated knee implant is designed for strength and stability for patients, and efficiency for surgeons and staff in the operating room.
Article Source:MDDI
