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A Colorado man recently filed a new Exactech lawsuit in the U.S. District Court for the District of Colorado. He claims that the Exactech Optetrak knee replacement device caused him serious injuries. He seeks compensatory damages.

Plaintiff Suffers Extreme Damage After Optetrak Knee Replacement Surgery

According to his complaint, the plaintiff went through total knee replacement surgery on December 9, 2014. His surgeon implanted in his left knee the following components:

  • Optetrak asymmetric femoral component (goes into the thighbone)
  • Optetrak logic fit tibial tray (sits on top of the shinbone)
  • Optetrak 1-peg patella component (the kneecap component)
  • Optetrak CR slope tibial insert (a plastic component that goes between the shin and thigh as a shock absorber)

On July 9, 2020, the plaintiff states that his Optetrak knee system “catastrophically failed.” Upon examination at the hospital, doctors determined that he had suffered a fracture of the distal femur (area of the leg just above the knee joint), proximal tibia (upper portion of the shinbone), and fibula (the thinner of the two lower leg bones).

Due to the severity and complexity of the plaintiff’s injuries, he had to be transferred by ambulance to Presbyterian St. Luke’s Hospital in Denver, Colorado. There, doctors diagnosed him with a failed left total knee replacement, massive osteolysis (a condition where bone tissue is destroyed), and tibia fracture with massive bone loss.

On July 10, 2020, the plaintiff underwent knee revision surgery. An orthopedic surgeon and a plastic and reconstructive surgeon participated in the surgery. They had to remove a significant amount of the plaintiff’s tibia and replace it with a metal device.

After the surgery, the orthopedic surgeon noted massive bone loss, a “grossly unstable tibia,” and significant wear debris from the polyethylene tibia insert.

While the surgery was considered successful, because of the severe damage, the plaintiff states that he will most likely need to have an above-the-knee amputation on his left leg in the future.

Exactech Took Too Long to Recall Faulty Components

The plaintiff blames his injuries on the faulty polyethylene insert that was part of his Optetrak knee replacement system. Exactech issued a Class 2 device recall of many of these components on August 30, 2021. Later, on February 7, 2022, the company expanded that recall to include all Exactech ultra-high molecular weight polyethylene knee and ankle polyethylene inserts, as these were packaged in out-of-specification vacuum bags.

These bags were oxygen resistant but did not contain a secondary barrier that further augmented the oxygen resistance. The use of these bags could lead to premature wear of the inserts, which could lead to bone loss and component fatigue and fracture, all leading to the need for revision surgery.

The plaintiff claims that Exactech was aware that its Optetrak device was defective. Yet it continued to aggressively market and sell the device while maintaining that it was safe and effective for use in total knee replacements.

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