In the months since medical device maker Exactech expanded the recall of its knee, hip and ankle replacement systems manufactured since 2004, the manufacturer has faced a growing number of lawsuits alleging that the packaging used for the polyethylene implant components was defective and caused the inserts to degrade and fail after being implanted in patients. According to allegations raised in Exactech lawsuits, it was the out-of-specification vacuum bags the polyethylene liners were packaged in that caused them to fail prematurely and expose recipients to complications like bone loss and implant loosening or fracture, among others. As a result of this alleged defect, knee surgery patients whose Exactech knee implants have failed prematurely may be eligible to bring a lawsuit against the company and pursue compensation for the pain and medical expenses they have encountered. To learn more about how to file an Exactech knee implant claim, contact Consumer Safety Watch today.
The Exactech knee recall announced in February 2022 affected more than 145,000 polyethylene liners used in Optetrak, Optetrak Logic, and Truliant knee replacement systems sold throughout the United States. According to the recall, the affected polyethylene liners were packaged in out-of-specification vacuum bags that allowed oxygen to diffuse into the inserts prior to implantation. Because the non-conforming vacuum bags did not contain a secondary barrier layer that would have prevented the polyethylene inserts from being exposed to oxygen, knee surgery patients implanted with recalled Exactech Optetrak, Optetrak Logic, or Truliant knee devices may experience premature wear or failure of the implant requiring early revision surgery. Possible complications that have been linked to the early degradation of the polyethylene liners in Exactech knee implants include pain, swelling, implant loosening or fracture, joint instability, bone loss, and other problems resulting in the need for revision surgery.
In a recent Exactech lawsuit filed earlier this month in the U.S. District Court for the Eastern District of New York, plaintiff Lawrence Daly claims that he experienced premature failure of his Exactech Optetrak knee device, due to packaging defects that allowed oxygen to diffuse into the polyethylene insert prior to implantation. Daly states in his claim that he received a recalled Exactech knee implant during a bilateral knee replacement surgery he underwent in October 2011. Within 10 years, Daly was experiencing severe pain in his left knee and underwent revision surgery to have the knee implant removed. Daly blames the unexpected failure of his Optetrak knee implant on premature wear of the polyethylene component. He states that his right knee is also failing and will require revision surgery in the future.
Most knee surgery patients implanted with recalled Exactech devices are just now being notified about the Exactech knee recall and the potential for their knee implant to fail prematurely. However, Daly claims in his Exactech lawsuit that the manufacturer was aware of and began receiving complaints about problems with its knee devices years before initiating a recall, yet allowed surgeons to continue implanting the devices in unsuspecting patients. “At all times relevant, Defendants have been aware of a high rate of early failures associated with the Optetrak Device,” Daly’s lawsuit states. “Despite Defendants’ knowledge of early onset failures of the Optetrak Device, Defendants continued to manufacture, promote, and distribute the Optetrak Device without alerting surgeons or patients of the potential increased risks of early onset failures of the Optetrak Device.”
Emerging evidence suggests that Exactech ignored signs of a problem with its knee implants for years and exposed patients to an unnecessary risk of future complications and additional surgeries by failing to initiate a device recall sooner. Now that Exactech has finally acknowledged the issue with its polyethylene inserts and taken steps to remedy the problem by removing the affected Exactech knee implants from the market, knee surgery patients will no longer be implanted with the defective devices. Unfortunately, for the thousands of patients who received recalled Optetrak, Optetrak Logic, and Truliant knee replacement systems that are vulnerable to higher-than-expected failure rates because of damaged polyethylene components, the recall offers little relief. If you received a recalled Exactech knee implant and have suffered pain, implant loosening, bone loss, or another serious complication, contact Consumer Safety Watch today, to find out if you are eligible to join the growing Exactech knee implant litigation.