Exactech’s Optetrak knee replacement has been the subject of a large number of reports of premature failure submitted to the FDA.

The Optetrak knee replacement had been on the commercial market since the mid-nineties, having been short-cut through the FDA approval process through the agency’s 510(k) program, which is highly controversial.

This program allows for product manufacturers to claim that their medical device is enough like an already commercially approved product that it doesn’t need the full assortment of clinical trials and safety testing normally required for a completely new device.

According to the FDA website, “enough like” is also known as “substantial equivalence.” It doesn’t necessarily mean identical, but it must be for the same marketed use and have technological aspects in common.

Optetrak Knee Implant Problems

The Optetrak knee replacement is not unlike other knee prosthetics. It is made up of a femoral component, a polystyrene insert, tibial tray, and tibial stem. These parts, when put together and implanted surgically after removing the natural elements in a diseased joint, mimic the complete function of this vital joint.

It was ostensibly a successful product until the company changed the nature of the cushioning polystyrene insert in 2011-2012. The insert’s shape was modified to be more “fin-shaped” and this seemed to create problems with the stability of the cemented tibial stem supporting the tray.

The FDA received numerous complaints regarding the finned polystyrene insert of the Optetrak knee implant for some time after the changeover. At least a quarter of recipients said they were using painkillers daily, and many were showing signs that the prosthetic was loosening and failing.

Thirteen known patients were pushed to the point of needing and getting the device removed and replaced in knee revision surgeries. A knee prosthetic should provide a patient with many years of improved joint function.

An Alabama man filed a lawsuit against Exactech, the device’s manufacturer, in October 2017. He alleged in the narrative of his Optetrak knee implant lawsuit that Exactech knew of the problems that fin-shaped inserts were causing and started to change the product’s inserts back to the previous configuration without notifying the public or medical community. Counsel referred to this as a “silent recall.”

The plaintiff in this lawsuit alleged he experienced a significant pain and suffering, and he claims permanent injuries connected to the implantation of the Optetrak knee implant. He alleges that he has and will need ongoing medical care and rehabilitation because of the prosthetic.

He believes that the company withheld key information from the public and failed to warn deliberately, which affected his choice of prosthetic made in conjunction with his physician.

Symptoms of implant failure for a total knee replacement patient, accounting for an average amount of post-surgical healing time, could be continued inflammation and swelling, infection, bone fractures, and difficulty ambulating.

If you feel that you or a loved one have suffered as a result of a defective knee prosthetic, you may qualify for a free case review with a medical device attorney.

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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