FDA communication on Exactech Joint Replacement Devices Defective Packaging

Direct from the FDA:

The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers about Exactech joint replacement devices manufactured by Exactech between 2004 and August 2021, and recalled in 2021 and 2022. Many Exactech joint replacement devices (including knees, ankles, and hips) were packaged in defective packaging bags. The defective bags 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. Some of the recalled devices are associated with increased risk of revision surgeries and bone loss related to excessive device wear/failure. 

Device Descriptions

Exactech joint replacement devices are used to replace painful, arthritic joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and loss of normal structure and function in adults. These devices are also used to improve previously failed joint replacement devices with adequate bone and soft tissue are present. All Exactech joint replacement devices contain a plastic component which should be in packaging that contains multiple oxygen barrier layers as indicated in the package specification. The recalled devices were packaged in defective bags that were missing one of the oxygen barrier layers that protect devices from oxidation.

Defective bags may allow oxygen from the air to contact the plastic (polyethylene) component before it is implanted into a person’s body. If a large amount of oxygen contacts the plastic component before the device is implanted, it may lead to oxidation of the plastic component over time that can result in the risk of:

• early and excessive device wear,
• component fracture, 
• device failure,
• new or worsening pain,
• more bone loss,
• swelling in the affected area, or
• revision surgery as a result of these issues.

Devices with Defective Packaging

• Knee and Ankle Replacement Devices
  On February 7, 2022, Exactech expanded a voluntary recall on all Optetrak, Logic, and Truliant knee replacements and Vantage total ankle replacements packaged in defective bags 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. Devices packaged in defective bags can lead to oxidation over time that results in the potential risks listed above. 
  
  On April 7, 2022, the company issued an updated Urgent Medical Device Correction notice with additional identified devices advising surgeons, hospitals, and health care providers to avoid implanting devices that were packaged in defective bags. Devices in defective bags were manufactured between 2004 and August 2021, and possibly implanted through February 7, 2022. The FDA classified these as a Class II recall on October 4, 2021. 
• 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. The FDA classified these as a Class II recall on July 22, 2021. 
  
  In August 2022, Exactech expanded the hip replacement device recall to include all hip devices with polyethylene components packaged in defective bags. The FDA classified these as a Class II recall on September 9, 2022. 

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. 

Patients who have received a hip, knee, or ankle implant since 2004 that was manufactured by medical device company Exactech, please contact us and your physician for guidance on what you need to know and do to prevent further injury and to make an Exactech implant recall claim.

This recall may affect hundreds of thousands of people across the U.S. who may have experienced premature wear of the plastic insert of the hip, knee, or ankle replacement that can lead to the need for additional surgery (also known as revision surgery).

We are also processing injury claims for the Exactech hip, knee, and ankle replacement systems. Problems with the Exactech hip, knee and ankle systems are highlighted by a recent study in ScienceDirect on early polyethylene failure in prosthesis.

From the ScienceDirect article:

Twelve patients were identified, with nine undergoing revision surgery. All patients demonstrated radiographic osteolysis at the time of revision surgery….the Exactech Connexion GXL liner may be prone to a high rate of early failure from wear and severe secondary osteolysis. https://www.sciencedirect.com/science/article/abs/pii/S0883540319311921

Source:

https://www.fda.gov/medical-devices/safety-communications/risks-exactech-joint-replacement-devices-defective-packaging-fda-safety-communication

FDA communication: Exactech Joint Replacement Devices Defective Packaging Page Updated on 4/12/2023