Exactech Recalls Defective Knee Replacement Systems
There has been a massive recall of Exactech knee replacement systems. More than 140,000 of these systems contain defective parts that can cause the medical implants to fail and result in the need for corrective surgery.
Exactech sent a recall notice to surgeons across the US on February 7, 2022. The notice warned that defective packaging might lead to the premature deterioration of some parts of the Exactech knee replacement system. This “accelerated polyethylene wear” was causing a “statistically significant” rate of component failure and revision surgery compared to the data of other knee replacement systems.
What Exactech Devices Are Part of the Recall?
Exactech began recalling knee replacement parts in August 2021. At that time, Exactech recalled only those knee replacement systems that were a few years away from expiring.
Since then, however, Exactech has acknowledged that current knee replacement systems contain the same problem – “non-conforming” bags for the polyethylene inserts, which can cause the premature deterioration of the parts.
As of now, all Exactech Optetrak, Truliant, and Optetrak Logic knee replacement systems sold since 2004 are part of the recall. It makes no difference what the remaining shelf life is. Nearly 150,000 devices are part of this recall. The precise number of patients who have had knee replacement surgery using these defective Exactech systems is unknown. There are potentially thousands of individuals with knee replacements that can deteriorate prematurely and result in pain, discomfort, and the need for additional surgery.
Packaging Defect Results in Exactech Knee Replacement Recall
Exactech introduced its Optetrak knee replacement system to the US in 1994. However, Exactech has acknowledged that since 2004, the packaging for the systems contains a defect that can result in the premature deterioration of specific components of the knee replacement system.
Specifically, the knee replacement systems contain polyethylene inserts that are implanted between the various components of the replacement knee. The packaging of these inserts is defective and allows oxygen to reach them before they get implanted in someone’s body. The oxygen causes the polyethylene to wear-out, oxidize or become damaged long before it should. Once these parts are implanted into the body, they fail far sooner than expected.
Defective Knee Replacement System Causes Injuries
The defective packaging system and the resulting failure of knee replacements can result in complications for unsuspecting patients.
Injuries from Exactech knee replacement failure can include:
- Bone loss
- Inability to bear weight
- Revision surgery or other medical procedures
Call Our Knee Replacement Lawyers For a Free Evaluation of Your Exactech Optetrak Lawsuit
During the last several years, even before the recent Exactech recall, patients filed lawsuits over the high failure rate of Exactech Optetrak knee replacement systems. Now, since the recall, many more are expected.
If you or someone you loved received a knee replacement using an Exactech Optetrak, Optetrak Logic, or Truliant knee replacement system, call our lawyers at Alonso Krangle, LLP.
Our Exactech knee replacement lawyers can tell you if you might be eligible to file a lawsuit or receive a settlement from the makers of these defective medical devices.
Call us today at 800-403-6191 for a free evaluation of your Exactech knee replacement lawsuit. Find out if you are eligible to receive compensation from the makers of these defective medical devices.