Exactech Hip Recall Expanded to Include Another 40K Implants, As Lawsuits Continue to Mount

After recalling nearly 250,000 knee, hip and ankle replacements over the past year, due to problems problems with polyethylene liners, the Exactech hip recall has been expanded to include another 40,000 components that may be defective and prone to fail.

Exactech sent an urgent Dear Healthcare Professional (DHCP) letter (PDF) last week, expanding a hip implant recall involving acetabular hip liners used in its Connexion, GXL, Acumatch, MCS and Novation systems.

The additional components were identified months after the company previously announced a massive Exactech polyethylene insert recall in February, which impacted more than 140,000 Optetrak, Optetrak Logic and Truliant knee replacement systems that had been implanted in patients since 2004, as well as 1,500 similar components used in Exactech Vantage ankle replacements.

At that time, the manufacturer warned that the polyethylene inserts were packaged in “out-of-specification” vacuum bags, which exposed the plastic parts to oxygen before surgery, increasing the risk of premature failure once the implant is in the body. However, the company did not indicate at that time that the packaging defect impacted Exactech hip replacements.

In June 2021, the company did recall nearly 90,000 recalled Exactech Novation and Acumatch hip implants used since 2008, indicating that those components were prone to exhibit early signs of failure due to problems with a polyethylene Connexion GXL acetabular liner. However, the company now indicates that another 40,000 components may experience similar problems.

The move comes as the U.S. Judicial Panel on Multidistrict Litigation (JPML) is considering a request to centralize and consolidate all Exactech knee replacement lawsuits and Exactech hip replacement lawsuits already filed throughout the federal court system, since they each raise common questions of fact and law regarding the use of defective liners.

The expanded recall notice now indicates additional components may be impacted, including the Acumatch GXL introduced in 2005; the MCS GXL, approved in September 2005; and the Novation GXL approved in March 2007, in addition to the Exactech All Polyethylene Cemented Cup approved in September 1996; the Acumatch Conventional UHMWPE approved in November 1993; the MCS Conventional UHMWPE approved in October 1993; and the Novation Conventional UHWMPE approved in July 2007.

“Exactech has identified an additional risk factor for premature wear that was not known at the time of the prior DHCP communication,” the letter states. “GXL inserts manufactured since 2004 were packaged in out-of specification vacuum bags that are oxygen resistant but do not contain a secondary oxygen barrier layer known as ethylene vinyl alcohol (EVOH), which further augments oxygen resistance.”

The manufacturer is urging surgeons to follow-up with patients to include all patients who received a GXL liner, regardless of the packaging materials, in the past 12 months, regardless of packing material. Surgeons are also urged to follow up with patients who received conventional UHMWPE acetabular liners which were packaged in nonconforming packaging which have not been examined in the past 12 months.

The company is not recommending the removal of recalled hip replacements that are functioning and not painful at this time. However, it is likely that many patients may be aware that prior problems with their hip implant were caused by a product defect, and the move is expected to expand the scope of the current litigation against Exactech.