Exactech Knee Devices Recalled Due To Increased Rates Of Failure And Need For Revision Surgery
Exactech Knee Devices Recalled
On August 30, 2021, Exactech, a medical device company, initiated a Class 2 recall of certain lots of their OPTETRAK, OPTETRAK with Logic, and TRULIANT knee replacement systems. Exactech issued the recall following concerning reports of increased rates device failure leading to the need for revision surgery. Upon investigation, Exactech discovered that many of its knee devices were improperly packaged in “out-of-specification” vacuum bags.
The Exactech knee systems include polyethylene (plastic) insert components. When distributed, these components should be packaged in oxygen resistant two-layered vacuum bags to prevent polyethylene oxidation and degradation. However, since 2004, most device inserts have been improperly packaged. This allowed the device components to be subject to oxygen exposure. When exposed to oxygen, the plastic insert components degrade. When these compromised Exactech components are then used in a knee replacement surgery, the patient is at risk of suffering device failure, device cracking, premature wearing of the device, and osteolysis. This can lead to pain, discomfort, impaired use of the knee, and ultimately the need for a revision surgery. Exactech is recommending that patients consult with their surgeons if they are experiencing any new or worsening knee swelling, pain while walking, inability to bear weight, or grinding. Likewise, patients should consult their surgeons if they notice instability or clicking in the knee.
In its recall, Exactech acknowledges that data from around the world reveals an increased risk of device failure in the OPTETRAK knee systems. Combined device registry data from Australia, New Zealand and the United Kingdom show significant increased reporting of revision surgeries due to accelerated wear of Exactech’s plastic knee components. Exactech suggests the improper packaging may be related to these problems.
To check if you or your loved one’s knee device is part of this Exactech Recall, you can check the Exactech website here.
Contact a Product Liability Lawyer at Burg Simpson for Help Now
If you are a loved one has suffered an injury and/or required a revision surgery after being implanted with a Exactech Knee Replacement System, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call (888) 895-2080 or fill out our contact form for a FREE no-obligation consultation today.
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