Optetrak TKA patients have been suing Exactech over poly failure from an alleged packaging issue.

This is one to watch for the whole ortho industry.

There have been numerous lawsuits filed against Exactech, the manufacturer of the Optetrak knee implant, alleging that the device is defective and can cause a variety of problems, including pain, swelling, instability, and failure.

The first lawsuit against Exactech was filed in 2017, and since then, there have been hundreds of additional lawsuits filed. The lawsuits allege that the Optetrak knee implant is defective because it contains a plastic insert that can wear down and break over time. When the insert breaks, it can release metal particles into the joint, which can cause inflammation, pain, and other problems.

In 2019, Exactech issued a recall of all Optetrak knee implants manufactured before August 2016. The company advised patients who have received an Optetrak knee implant to consult with their surgeon to determine whether the implant needs to be replaced.

In addition to the lawsuits, the U.S. Food and Drug Administration (FDA) is also investigating the Optetrak knee implant. In 2020, the FDA issued a warning letter to Exactech, stating that the company had failed to provide adequate information about the risks associated with the Optetrak knee implant.

The status of the lawsuits against Exactech is still ongoing. The cases are currently in the discovery phase, which means that the parties are exchanging information about the case. It is expected that the cases will go to trial in the next few years.

If you have received an Optetrak knee implant, you should consult with your surgeon to determine whether the implant needs to be replaced. You should also contact an attorney to discuss your legal options.

Thousands got Exactech knee or hip replacements. Then, patients say, the parts began to fail. (CBS News)

Ron Irby expected the artificial knee implanted in his right leg in September 2018 would last two decades — perhaps longer.

Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced — a painful and debilitating operation.

“The surgery was a huge debt of pain paid over months,” said Irby, 71, a Gainesville resident and retired medical technologist with the Department of Veterans Affairs.

Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. A letter Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants. Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.

From one law firm – https://www.schmidtandclark.com/exactech-knee-lawsuit

Update: Exactech Knee Replacement Lawsuit Filed Over Knee Implant Failure

A product liability lawsuit [1] recently filed in Tennessee alleges that packaging problems caused the premature failure of an Exactech Truliant after a polyethylene insert degraded, resulting in the need for revision surgeries only a few years after the device was implanted.

The lawsuit was filed on behalf of Plaintiff Billy Hursey, who claims he received an Exactech Truliant Posterior Stabilized Knee System in July 2021 during a joint replacement surgery.

After suffering from pain, instability, synovitis, and swelling, which ultimately resulted in his inability to walk, Hursey had the implant removed during revision surgery in August 2022. During the operation, the surgeon noted that the tibial insert was damaged along the medial edge, which the lawsuit claims were a direct result of the packaging defects.

“As a result of Defendants’ failure to properly package the Truliant Device prior to distribution, the polyethylene liner prematurely degraded and Plaintiff Billy Hursey required revision surgery due to severe pain, swelling, and instability in the knee and leg,” the complaint states. “These injuries were caused by early and preventable wear of the polyethylene insert and resulting component loosening and/or other failures causing serious complications including tissue damage, osteolysis, permanent bone loss and other injuries.”