Exactech Knee and Ankle Devices Recalled
Burg Simpson Investigates Recalled Exactech Knee and Ankle Devices
Alarming rates of failure and revision surgeries have led medical device manufacturer Exactech to recall several knee and ankle replacement systems. In August 2021, Exactech began recalling their OPTETRAK Knee, OPTETRAK with Logic Knee, TRULIANT Knee, and VANTAGE Ankle Systems. These knee and ankle systems have plastic components made of Ultra High Molecular Weight Polyethylene (UHWMPE). The plastic components are supposed to be packaged and distributed to hospitals and/or surgeons in oxygen-resistant vacuum bags that contain a secondary barrier that includes ethylene vinyl alcohol (EVOH) – a compound that assists in preventing exposure to oxygen. Exposure to oxygen can cause oxidation of the plastic devices. Over time, oxidation can damage the structural integrity and mechanical properties of the plastic components of Exactech’s knee and ankle systems.
As revealed in Exactech’s Recall Notice, since 2004, Exactech has been distributing plastic components of these knee and ankle systems in bags that did not contain the secondary barrier to protect from oxygen exposure and subsequent oxidation. In fact, even after initiating the recall in August 2021, Exactech continued to ship improperly packaged knee and ankle devices, leading to the need for a second expanded recall on February 7, 2022.
The risks associated with oxidized plastic components are significant. In a letter to doctors, Exactech explained that oxidative damage to the plastic components may accelerate “wear debris production and bone loss, and/or component fatigue/cracking/fracture all leading to corrective revision surgery.” Patients are advised to alert their doctors if they experience swelling, pain, inability to bear weight, grinding, instability, or clicking.
Currently, over 147,700 improperly packaged Exactech devices subject to oxidation have been implanted in patients across the United States. Data from European and Australian medical device registries have reported statistically significant increased revision rates for the OPTETRAK Knee System. Furthermore, in the New Zealand medical device registry, data showed that 9.5% of patients with a primary OPTETRAK total knee replacement required a revision.
If you have an Exactech knee or ankle device and are suffering from pain, swelling, instability, inability to bear weight, or require revision surgery, contact Burg Simpson today!
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If you or a loved one have been injured by a recalled Exactech Knee or Ankle device, contact one of our experienced mass tort lawyers today by calling (888) 895-2080.
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