In the fall of 2011, Exactech Inc.—makers and distributors of the Optetrak knee replacement system—initiated a recall of the knee prosthetic’s tibial tray. The U.S. Food and Drug Administration (FDA) announced this Optetrak knee replacement tibial tray recall in late July of the following summer.

Although this recall was ostensibly for ‘mislabeling’ issues and only technically affected 16 units, the tibial tray reportedly had other issues seeming to stem from instability of its stem which is cemented into the top of the larger of two lower leg bones.

According to reports filed with the FDA’s MAUDE reporting system, the Optetrak knee replacement system has been linked to several cases in which recipients suffered prosthetic failure leading to the need to have the device removed and replaced in early revision surgery.

The tibial tray of the Optetrak knee replacement system was often linked to these failure scenarios with complaints of pain, feeling of instability, and general sense of loosening.

Upon removal, most of these units were reportedly discovered to have significant wear and tear beyond what would be expected for the amount of time the device had been implanted.

The cause of these complications was believed to stem from the junction where the tibial tray cemented into the lower leg bone. The lack of good adherence at this junction purportedly caused the polyethylene insert to fragment unnecessarily and age the device, making surgery to remove the Optetrak knee replacement inevitable. Another reported problem related to the wear and tear, fragmentation, and lack of cement adherence was deep joint infection.

Performance of the Optetrak Knee Replacement System

According to a study reviewed in the medical journal Orthopaedics and Traumatology: Surgery and Research, the performance of the Optetrak knee replacement system has been less than stellar. The study followed 110 devices in 106 patients (some of them had bilateral prosthetics) for a little over two years after implantation.

The patients reported extreme pain, swelling, infection, fracturing, reduction in range of motion, and problems with knee joint stability. Nearly a quarter of studied total knee arthroscopy (TKA) patients said they relied on painkillers—both over-the-counter and prescription—regularly to cope with the discomfort related to the prosthetic.

Another near quarter of the studied patients experienced loosening at the tibial juncture, according to the researchers. Fifteen percent reported dissatisfaction related to their Optetrak knee replacement while 13% needed early revision or opted for it based on this discontent with its performance.

Recouping Funds Expended for Knee Revision Surgery

Filing a knee revision surgery lawsuit can help a TKA patient recover funds lost through not being able to work, incurring high medical and hospital bills, and in some cases, not being able to earn wages in the future due to disability.

While a lawsuit cannot undo the pain and suffering, it can help ensure that manufacturers take their responsibility to the health and well-being of others seriously.

Get a Free Knee Replacement Case Review

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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