The wait continues.

Ron Irby has patiently been biding his time since suing the maker of his defective knee implant several years ago, waiting for justice. 

But it appears that reparation is still out of reach. For now, anyway.

Irby, 73, is among thousands of patients who are seeking to hold Exactech Inc. liable for its recalled knee, hip, and shoulder implants. Many of the lawsuits blame the device flaw on a packaging shortcoming that caused oxidation in some of the products, outright damaging them or shortening their lifespan. Irby’s Optetrak knee, for example, wore out and had to be replaced after just three years.

In his lawsuit, Irby claims that Exactech “knew or should have known” the Optetrak knee had an unacceptable failure and complication rate, CBS News reported. He also accused the Gainesville, Fla.-based company of using inferior-grade packaging materials, according to the news outlet. 

“I think they were cutting corners to improve their bottom line,” the retired medical technologist told KFF Health News.

Exactech refuted Irby’s allegations, stating in a legal filing that its Optetrak knee is “safe and effective,” CBS News declared. However, in 2022, the company acknowledged the packaging defect that could have prompted the implants’ premature demise.

In an April 7, 2022, letter to patients, Exactech details the potential packaging problem, explaining that one of the packaging layers for a plastic (patellar component, tibial polyethylene or partial tibial polyethylene) insert was “out-of-specification” and could have allowed oxygen to diffuse into the plastic insert before the artificial joint was implanted in the knee. Such a packaging failure could trigger oxidation, which can quickly erode plastic. “Exactech has found that the tibial plastic insert in the out-of-specification bag can wear out earlier than expected in some patients. Premature wear of the plastic insert…can lead to the need for additional surgery…” the letter read.

Exactech eventually recalled more than 657,000 defective hip, knee, ankle, and shoulder implants manufactured between 2004 and August 2021. Affected brands included Novation, AcuMatch, MCS (hips); Optetrak Logic, Truliant, Arthrofocus (knee); Vantage (ankle); and the Equinoxe Shoulder System. 

In its letter to patients, Exactech pledged clinical and financial support to recipients experiencing issues with their joint replacements. Once recall-related lawsuits began mounting, Exactech began working with a third-party company to handle the claims.

Many of the patients suing Exactech are seeking reimbursement for out-of-pocket costs, such as medical bills from doctor visits, revision surgery, and of course, the pain and suffering associated with their defective implants.

“The surgery was a huge debt of pain paid over months,” Irby told CBS News in October 2023.

Irby and other plaintiffs may not be compensated for that debt anytime soon, though. Saddled with legal expenses and high interest payments, Exactech filed for bankruptcy last fall, pausing all lawsuits. Having spent $20 million on recalls and litigation between October 2023 and October 2024, the company filed for Chapter 11 protection owing $352 million to debtors. The sale agreement at the time of the filing called for turning over Exactech’s assets to its lenders.

The company’s owner, private equity firm TPG Capital, tried shielding itself from liability by offering up an $8.1 million settlement that would have prevented individual claimants from recouping any monetary damages from TPG. Creditors’ resistance to the settlement, however, forced the Texas-based entity to abandon the proposal this past spring. 

TPG not only abandoned the proposal, but Exactech as well. A revised bankruptcy plan that emerged earlier this summer (and is endorsed by creditors) calls for Exactech to sell its assets to a new ownership group. The proposal would allow legal claims to continue as Exactech continues operations through a $60 million fiscal infusion (roughly $150 million total) from its new owners. 

“This agreement represents a significant milestone on the path to Court approval of our plan of reorganization and emergence under new ownership,” Exactech President/CEO Darin Johnson said in announcing the new reorganization plan. “We look forward to the Court’s approval of the sale and confirmation of the plan…Throughout this process, we have continued to develop and provide high-quality medical devices for our surgeons and their patients, and we will accelerate this progress as we emerge with a stronger foundation for long-term growth in partnership with our new owners.”

The bankruptcy plan is expected to be approved by the court in early September. Once that occurs, the company’s new owners—Strategic Value Partners LLC (together with its affiliates, SVP), Stellex Capital Management LLC, and Greywolf Capital Management LP—will acquire substantially all of Exactech’s operations and assets free and clear, forming a new company. 

Maybe then justice for Irby and thousands of others will finally be served.