Thousands of patients across Australia may be affected by Exactech product recall

A US maker of replacement knees issued a product recall after its products were found to be faulty, but lawyers have revealed why patients are unlikely to receive compensation.

Exactech promotional photo as seen on their website and Facebook page. Picture: Exactech

Queensland patients who received one of the thousands of defective knee, hip, or shoulder replacements will learn in a fortnight if they will receive a payout from the failing US manufacturer, as lawyers leading a class action sit down for an 11-hour round of mediation.

If they cannot secure a payout at mediation on February 12, the patients will be left to line up as unsecured creditors after Exactech filed for bankruptcy in the US.

Diana Chapman, of Gerald Malouf and Partners, said that any hope of patients receiving compensation would diminish if there is no result at mediation.

“It has been really bitter,” Ms Chapman said.

“We did have mediation on December 20 but there was no offer made.”

The firm filed its class action in 2023 on behalf of more than 330 claimants, but Ms Chapman alleged there would be upwards of 4500 patients across Australia who have received faulty Exactech replacements, dating back as far as January 1, 2003.

GMP is suing Exactech Australia and Exactech Incorporated.

Exactech issued a product recall in 2021 after it found its knee, shoulder, hip and ankle replacements were defective as a result of improper storage.

The products were exposed to oxygen which caused them to degrade, shortening their lifespan and leading to patients requiring complicated revision surgery where the faulty implants are removed and replaced.

According to US-based KFF Health News, orthopaedic surgeons had identified problems with the Exactech replacements and raised their concerns with the company as early as 2006.

This included claims that the components were degrading about 2-3 years, while components from other manufacturers typically last 10 years or more.

“The implants are okay for about 12 months, then they start to fail,” Ms Chapman said.

GMP alleged that faulty replacements caused patients to suffer a range of complications including pain, swelling and bone death.

The replacements can cause patients’ bones to rot from the inside out, causing infection, significant amounts of pain and changing how patients walk.

The Australian firm’s class action is one of 2600 lawsuits filed against Exactech globally.

In response to the snowballing lawsuits and the costly recall, Exactech filed for bankruptcy in November last year, with debts over $350 million.

Ms Chapman said Exactech’s investors signalled they will buy out the bankrupt company in a process they would wash away its liability for the faulty replacements.

“The new firm won’t be taking on the debt,” she said.

“They can’t do it in Australia, but they can do it in the US.”

According to data sourced from the Australian Orthopaedic Association National Joint Replacement Registry, a significant number of those fault implants, namely the company’s knees, were installed at St Vincent’s Private Hospital.

The registry’s records show about 1800 Australian patients were at risk of needing revision surgery for their Exactech knee implants last year. Of those, more than 600 are St Vincent’s hospital patients.

A St Vincent’s Health Australia spokesman said the hospital was aware of the recall and was working with Exactech to seek appropriate redress for patients who require replacements.

“The decision around which prosthesis or device to use is always a matter between a visiting medical specialist and their patient,” he said,

“We have communicated the details of the recall to all St Vincent’s medical specialists.

“We are providing support to the medical specialists involved to help them engage with impacted patients.

“Given the legal matters involved, we are restricted in making further

comments, but will continue to work closely with our patients and medical specialists on the matter.”

Anyone with an Exactech Optetrak replacement should check with their doctor to see if they need revision surgery.

Originally published as Thousands of patients across Australia may be affected by Exactech product recall