Gainesville medical device manufacturer files for bankruptcy amid implant allegations

Exactech, a Gainesiville-based device manufacturer facing more than 2,000 state and federal lawsuits filed by patients who say the company sold defective hip and knee implants, filed for bankruptcy protection on Tuesday.

Business – wrote in the statement was in the restructuring phase and was to be sold to an investor group consisting of private equity firms and alternative asset firms, which would provide the company with approximately $85 million in business financing.

Exactech president and CEO Darin Johnson said in a statement that the company faces “unsustainable liabilities related to knee and hip litigation related to packaging recalls that we voluntarily initiated in 2021-2022.” The company said it would continue its operations during bankruptcy proceedings.

“We take our commitment to patient well-being very seriously and provide patients with significant out-of-pocket reimbursement and surgeon support for associated expenses,” Johnson said.

Bankruptcy proceedings in federal court in Delaware will halt lawsuits for patients seeking compensation.

The surprising action terrified lawyers representing injured patients.

“The announcement of Exacttech’s bankruptcy is a slap in the face to all patients with joint implants and doctors who trusted this company. A medical device company that sells products for implantation in the human body has a special responsibility for public health, said Joe Saunders, a Pinellas County-based attorney who sued the company on behalf of injured patients.

Saunders said the bankruptcy “is designed to conceal the public disclosure of the fact that the company is prioritizing profits over safety.”

“The announcement of Exacttech’s bankruptcy is a slap in the face to all patients with joint implants and doctors who trusted this company. A medical device company that sells products for implantation in the human body has a special responsibility for public health.”

Joe Saunders, a Pinellas County attorney who sued the company on behalf of injured patients

Injured patients expected one of the first jury trials against the company to begin in December in Alachua County Circuit Court. But the bankruptcy filing “halts the public process and hides the truth about the company’s conduct,” Saunders said.

Exactech, which over thirty years has transformed from a small device manufacturer into a global entity, was the subject of a KFF Health News investigation published October 2023

The investigation found that in hundreds of cases, the company took years to report adverse events to a federal database that tracks device failures.

Multiple lawsuits allege that the company’s knee and hip implants had “unacceptable failure and complication rates.” Exactech has denied the allegations, and the company has not commented on the lawsuits.

Exactech started a a series of reminders artificial knees, hips and ankles, starting in August 2021. Exactech initially blamed a packaging defect dating back to 2004 as the likely cause of premature wear of the plastic component in about 140,000 implants.

A KFF Health News analysis of more than 300 ongoing cases in Alachua County found that surgeons removed about 200 implants after less than seven years, well earlier than the typical 15-20-year lifespan of these products.

“I’m so angry. How did they (Exactech) think they were not responsible for this?” said Sue Sacher, 76, of New Jersey.

Sacher said she had her right knee replaced with an Exactech implant in 2006 and her left knee three years later – both at the Hospital for Special Surgery in New York.

She has since replaced both implants.

KFF Health News is a nationwide newsroom dealing with broadly understood journalism about health issues and is one of the main operational programs of KFF – an independent source of research, surveys and journalism in the field of health policy. Find out more about KFF.