Exactech Truliant Knee Lawsuit Filed After Revision Surgery Caused By Degraded Polyethylene Insert

According to allegations raised in a recently filed product liability lawsuit, packaging problems resulted in the early failure of an Exactech Truliant knee replacement, after a polyethylene insert degraded and resulted in the need for revision surgery only a few years after the device was implanted.

The complaint (PDF) was filed last month in the U.S. District Court for the Middle District of Tennessee by Billy Hursey, indicating that his doctors used an Exactech Truliant Posterior Stabilized Knee System during a joint replacement surgery in July 2021, which was recalled by the manufacturer only a few months later.

An Exactech Trulian knee recall was issued in February 2022, impacting 24,727 components implanted since 2017, since they were distributed in defective vacuum bags, which failed to prevent oxygen from reaching a plastic insert before it was placed in the body. This resulted in oxidation of the components, making them prone to fail prematurely.

The case joins a growing number of Exactech knee lawsuit filed since the recall, which also impacted another 120,000 Optetrak and Optetrack Logic total knee replacement systems distributed since 2004, which have been linked to an alarmingly high failure rate for years.

The Exactech Truliant knee system was approved through the FDA’s 510(k) fast-track approval process, including a mix of polyethylene and metal components. The manufacturer promoted the device as “an evolution of the Optetrak lineage,” Hursey’s lawsuit states, without recognizing that long-standing packaging problems made the implants defective and unreasonably dangerous.

Exactech Truliant Knee Failed One Year After Surgery

According to the lawsuit, Hursey, of Tennessee, underwent left knee replacement surgery in July 2021, at which time he was implanted with a Truliant Posterior Stabilized Knee System, which was later affected by the recall.

After experiencing pain, instability, synovitis and swelling, which ultimately resulted in an inability to walk, Hursey had the implant removed during revision surgery in August 2022. At that time, the surgeon noted that the tibial insert was damaged along the medial edge, which Hursey indicates was 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 lawsuit 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.”

Lawsuits Over Exactech Truliant and Optetrak Knee Replacements

According to allegations raised in knee replacement lawsuits being filed against Exactech by Hursey and other plaintiffs, the manufacturer knew or should have known about high failure rates associated with Optetrak and Trulian knee implants long before doctors and patients were warned about the problems.

At least as early as 2017, lawsuits over Exactech Optetrak knee implants indicated there were alarming rates of adverse event reports being submitted to the FDA involving premature knee replacement revision surgery, which resulted in what some said was a “silent” Exactech recall when the company began slowly and quietly replacing the tibial trays of some Optetrak models.

In November, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all Exactech lawsuits in an MDL, or multidistrict litigation, and transferred the claims to U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, to coordinated discovery into common issues in the claims, avoid conflicting pretrial schedules and to serve the convenience of common witnesses and parties involved lawsuits that were spread out throughout the federal court system.

In addition to lawsuits over Exactech Truliant and Optetrak components, the litigation also includes Exactech hip replacement lawsuits filed over similar packaging defects with its Connexion GXL acetabular polyethylene liners, which have also been found to prematurely degrade and fail.