Lawsuit Alleges Exactech Truliant Knee Failed Due to Defectively Packaged Components, Resulting in Revision Surgery

A product liability lawsuit claims that an Exactech Truliant knee implant failed prematurely, requiring revision surgery and resulting in permanent injuries for a Pennsylvania woman.

The complaint (PDF) was filed by Mary Elizabeth Davis in the U.S. District Court for the Eastern District of New York on April 6, indicating that Exactech, Inc. sold defective knee replacements that contained a polyethylene insert that was prone to fail.

Davis is one of a growing number of individuals now pursuing an Exactech knee lawsuit, after a massive recall issued early last year, which impacted more than 140,000 components implanted since 2004.

According the Exactech recall, knee replacement systems were distributed in “out-of-specification” 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, leading to an alarmingly high failure rate for Exactech implants within a few years after knee replacement surgery.

Davis indicates she underwent left knee replacement surgery in December 2014, involving the use of an Exactech Truliant implant. However, following the surgery, she experienced worsening symptoms of pain, instability and discomfort, which were later determined to be caused by polyethylene particulate debris-induced extensive synovitis, osteolysis and effusion.

Subsequently, Davis received a recall letter indicating her Exactech Truliant implant was one of those recalled due to the risk of polyethylene insert wear and failure.

In July 2022, Davis underwent revision surgery to have the Exactech knee removed. However, she still experiences pain and discomfort on a daily basis in her left knee, which the lawsuit claims has limited her daily activities and quality of life.

“Defendants, through their affirmative misrepresentations and omissions, actively and fraudulently concealed from Plaintiff and Plaintiff’s health care providers the true and significant risks associated with the Truliant Device and the need to vigilantly do diagnostic procedures to promptly diagnose the insidious process of the toxic polyethylene particles degrading and causing osteolysis,” the lawsuit states. “Defendants know that after the one-year checkup following a total knee arthroplasty, patients are not typically expected to return for monitoring absent problems. Thus, Defendants knew that unless they informed surgeons to call their patients back for periodic radiologic monitoring, polyethylene chemical degradation and attendant osteolysis could be occurring unchecked until it reached the stage of severe bone loss.”

Davis’s lawsuit presents claims of defective manufacturing, defective design, failure to warn, negligence, negligent misrepresentation and breach of warranty. She is seeking both compensatory and punitive damages.

April 2023 Recalled Exactech Knee Implant Lawsuit Update

Davis’s lawsuit joins nearly 200 Exactech knee lawsuits filed in the federal court system, which are centralized before U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, since they each involve similar questions of fact and law about whether “out-of-specification” vacuum sealed bags caused a plastic tibial insert component to fail, leading to risky revision surgery.

In February, Judge Garaufis issued a docket order scheduling a Science Day for the morning of May 10, 2023, at the Alachua County Family and Civil Justice Center in Gainesville, Florida, before both himself and two state court judges presiding over similar cases.

Such proceedings typically involve non-adversarial presentations by expert witnesses or parties, which are intended to educate the court about issues and concepts that will come up during the proceedings. The presentations are not part of the official record in the case, or subject to cross examination. However, information presented may guide the Court in any future rulings or motions about evidence to be presented in the Exactech lawsuits, including decisions about which expert witness testimony may be presented to juries.

As part of the management of the litigation, it is expected that Judge Garaufis will establish a “bellwether” process, where a small group of representative claims will go through a case-specific discovery process and be prepared for early test trials, which will help determine potential settlement values by gauging the average Exactech lawsuit payout awarded for recalled components.