Exactech to Pay $8M to Settle Defective Knee Implant Suit

Exactech to Pay $8M to Settle Defective Knee Implant Suit

Introduction

Medical device maker Exactech has agreed to an $8 million settlement to resolve allegations that it hid defects in a widely used line of artificial knee implants.

The implants have been linked to thousands of patient injuries and sparked numerous lawsuits across the country. The agreement settles two whistleblower cases accusing the company of violating the federal False Claims Act by billing government health programs such as Medicare for defective knee replacement components.

Federal Prosecutors Emphasize Patient Safety

Announcing the settlement, the U.S. Attorney for the District of Maryland stressed that patients depend on device manufacturers to prioritize safety. “When a manufacturer discovers a defect, it must act quickly and transparently,” the prosecutor said. Although the settlement resolves government claims, Exactech has not admitted liability and declined to comment publicly on the deal.

Bankruptcy Leaves Patients Without Compensation

Exactech declared bankruptcy in October 2023, a move that has stalled thousands of injury claims. The U.S. Bankruptcy Court in Delaware has now approved the whistleblower settlement, but the company’s financial collapse has left injured patients in limbo. Many have undergone revision surgeries to remove and replace the implants—sometimes within three years of the original operation—and so far have received no compensation.

More Than 2,500 Injury Claims Filed

According to a Pinellas County attorney representing patients in separate lawsuits, more than 2,500 people have filed claims alleging injuries from Exactech implants. “There are people who are lifelong cripples from this or have had multiple surgeries,” the lawyer said. Because of the bankruptcy proceedings, most of these cases remain on hold.

Patients Frustrated With Government Settlement

Some patients have criticized the government’s settlement with Exactech, saying it does nothing to address their suffering. A New Jersey woman who had two Exactech knee implants replaced at the Hospital for Special Surgery in New York expressed anger over the outcome. “I’m fuming,” she said. “People are suffering, and the government is getting the money. Where are the patients? Who’s taking care of us?”

Private Equity Firm TPG Under Scrutiny

A committee of creditors is reportedly exploring legal action against TPG, the private equity firm that purchased Exactech for $737 million in 2018. TPG successfully fought off a similar attempt last year, arguing it had no operational control over the company. TPG has declined to comment on the current situation.

Whistleblower Lawsuits Detail Defects

The first whistleblower case, filed in 2018 in Alabama by two former Exactech sales agents and a former senior product manager, alleged serious flaws in the Optetrak total knee replacement system sold since 1994. According to the settlement, Exactech knew by 2008 that a key component was failing at unacceptably high rates but continued marketing the product through December 2018. The three whistleblowers will share $1.33 million under provisions that reward individuals who sue on behalf of the government.

In the second case, a Maryland orthopedic surgeon alleged that Exactech knew as early as January 2019 about premature failures in polyethylene components used in its Logic and Truliant knee systems. The company continued selling the devices until February 2022, when it expanded a recall. That whistleblower will receive $565,360 from the settlement.

Delayed Adverse Event Reporting

A 2023 report found that Exactech often reported adverse events to federal regulators years late—sometimes more than two years after discovering them. Such reports are supposed to be submitted within 30 days unless an exemption is granted. This pattern raised additional concerns about the company’s transparency and compliance with federal safety rules.

Implants Removed Far Earlier Than Promised

An analysis of more than 300 pending cases in Florida’s Alachua County revealed that surgeons removed roughly 200 knee and hip implants in less than seven years, far short of the 15–20 years these devices are typically expected to last. Exactech’s marketing had emphasized the durability of its implants, even suggesting they would likely outlast their recipients.

Company Denies Defects

Despite mounting lawsuits and whistleblower allegations, Exactech has consistently denied in court filings that its Optetrak implants were defective. The settlement represents only the resolution of government claims; thousands of private lawsuits and patient claims remain unresolved as the bankruptcy process continues.