Daniel Carson had an Exactech Optetrak knee replacement device implanted so that he could regain his quality of life. A few years after the knee replacement surgery, Carson's life was turned upside down. First, he learned that the knee replacement had failed and needed to be revised and then he was told part of his leg may have to be amputated due to the knee replacement failure.
Carson underwent a left knee replacement surgery in December 2014, involving an Exactech Optetrak knee system. However, the lawsuit indicates that the artificial knee failed suddenly in July 2020, when the polyethylene liner degraded and caused bone loss, osteolysis, significant debris and a grossly unstable tibia. The knee failure was so sudden and severe that Carson was immediately taken to the hospital by ambulance and underwent revision surgery the next day.
“While the July 10th, 2020, revision surgery was successful, because of the damage that his left leg sustained in the failure of his Optetrak knee system, in the future Plaintiff most probably will need to have an above the knee amputation of his left leg,” Carson’s lawsuit states.
Since Carson's revision surgery, Exactech has recalled more than 140,000 failed knee devices because they were packaged in “out-of-specification” vacuum bags that exposed the plastic components to oxygen before they were implanted. The manufacturer acknowledged at that time that the packaging defect increased the risk that the knee implant may degrade and fail once in the body.
In the recall notice issued earlier this year, the manufacturer now acknowledges the foreign registries have found a higher-than-expected rate of Exactech knee failures involving the poly liner, often resulting in the need for additional surgery only a few years later.
The Exactech knee devices are not the only ones that are under scrutiny. Exactech hip devices and ankles are also probes because of higher than acceptable failure rates.