The FDA has received multiple reports of Exactech Optetrak side effects that have led to early failure of the knee replacement device.

The U.S. Food and Drug Administration (FDA) has received multiple reports of Exactech Optetrak side effects. The reports were received through the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

Exactech Optetrak side effects may be linked to the device’s tibial tray, which has been found to be prone to wear and tear and was the subject of an FDA Class 2 device recall. The 2011 recall was initiated by Exactech for reported “labeling mix-ups”.

Detrimental Exactech Optetrak side effects were also supported by a study published in Orthopaedics & Traumatology: Surgery & Research. The study reviewed 106 patients 25 months after their initial knee replacement surgery.

Researchers found that some patients were affected by tibial loosening at the tibial plate. Exactech Optetrak side effects found in the study included: severe pain, limited range of motion, loss of mobility, swelling, inflammation, joint stability, infection, fracture, fragmentation, device wear, and loosening of the device.

The study also reported poor results in patient feedback due to Exactech Optetrak side effects. Of the patients reviewed, 15% said they were disappointed or dissatisfied. 22% of patients reported pain and the regular use of pain killers. 22% of patients were beginning to suffer from tibial implant loosening. 21% of patients had signs of patellofemoral conflict and 13 implants needed revision surgery.

The researchers noted that the tibial loosening was taking place at the cement-tibial-implant interface, reportedly as a result of the fragmentation and wear of the plastic insert.

“The microbead coating of the tibial implant was intended to facilitate grip between the tibial plateau and the cement, but the particular type of loosening at the cement–prosthesis interface with nearly nonexistent cement adherence has raised doubts in this area,” the researchers wrote in their study. “For the same reason, the role played by the lateral pockets under the tibial tray, designed to improve tibial cementing hold, remain unconvincing.”

Patients who developed complications due to Exactech Optetrak side effects may have to undergo revision surgery to fix the problem and replace the implant. Although revision surgery would resolve any previous issues with the knee replacement, there are significant risks and a difficult recovery associated with the surgery.

If component failure causes significant bone damage, a surgeon may have to graft new bone to compensate for the unusable bone. Additionally, if component failure resulted in tissue damage, recovery from an additional revision surgery can be more difficult on the patient.

According to the American Academy of Orthopedic Surgeons, potential complications of revision surgeries include pain, swelling, stiffness, infection, blood clots, bone loss, fractures, and reduced range of motion. More serious complications which are associated with any surgery include damage to nerves or blood vessels, pulmonary embolisms, lung complications, lung complication, or stroke.

If you or a loved one experienced detrimental Exactech Optetrak side effects, you may be eligible for a knee replacement lawsuit against the device’s manufacturers. A Exactech Optetrak lawsuit could help recover compensation for medical expenses, loss of wages, permanent disability, and more.

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If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.

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