Exactech Connexion GXL Hip Liners

Exactech Connexion GXL liners were used as part of its Novation and Alteon hip replacement systems. Featuring irradiated ultra-high-molecular-weight polyethylene (UHMWPE) plastic, these liners were intended to resist wear. Risks of premature wear were observed, however, and after studying the issue, the company notified surgeons in June 2021 that “the GXL liner has been transitioned entirely out of the US market.

GXL hip liners had been indicated for use in people who needed a total hip replacement because of osteoarthritis, osteonecrosis, rheumatoid arthritis, congenital hip dysplasia, ankylosing spondylitis and other degenerative hip problems. A 2022 study reported that, following a hip replacement, 46.7% of participants experienced a clinically significant improvement, while 15.5% experienced worsened outcomes, suggesting potential design-related issues impacting patient recovery and function. 

The move away from the GXL liners has meant a transition to XLE liners, also UHMWPE plastic, which Exactech describes as its “next generation polyethylene highly crosslinked Vitamin E liners.” The XLE liners received FDA approval in March 2018, and, according to Exactech, outperforms the GXL liners.

What Should I Do If I Have a GXL Liner?

Initially, Exactech did not describe the transition away from GXL liners as a recall. The company officially said, “No, Exactech is not recalling the GXL liner.” However, they advised hip replacement patients to speak with their surgeon. Your surgeon’s office can confirm the model and make of your hip replacement and if an Exactech GXL liner was implanted.

For those who confirm that their implant is an Exactech hip replacement system with a GXL liner and “are less than six (6) years from index surgery and who have not been seen in over 12 months” are advised to return to their surgeon’s office for an exam and x-rays to determine if there’s wear or deterioration. 

Replacement or revision surgery is not generally recommended, but for those with significant wear, this may be necessary. 

In March 2023, FDA confirmed that Exactech issued a recall for some GXL Liners for Novation, Acumatch and MCS hip replacements in June 2021. However, Exactech didn’t know why the devices suffered from excessive and premature wear. The FDA classified this as Class II recall in July 2022. Exactech then expanded hip replacement recall to include all devices packaged in defective bags in August 2022, and the FDA classified this as a Class II recall in September 2022.

Exactech Connexion GXL hip liners, also called acetabular liners, are one part of a complete hip implant.

In order to recreate the hip joint, implants have a ball that fits into a cup called an acetabular component. The component is made of an acetabular shell and a liner. This ball and cup fit into the hip socket. A stem attaches to the ball and connects to the thighbone.

Acetabular liners fit in between the ball and the acetabular shell. This allows the implant to move. The liners can be made of ceramic or plastic.

Exactech Connexion GXL hip liners are contraindicated in patients with severe infection, patients with neuromuscular disorders that affect the hip joint, and patients whose weight, activity level, or age would cause early failure.

Complications from Wear

Complications from hip replacement surgery are typically rare, but conditions like osteolysis can occur when debris from polyethylene wear builds up in the joint. It causes the surrounding tissue and bone to degenerate. This compromises implant fixation, increases the risk of aseptic loosening and necessitates early revision surgery, particularly in cases of accelerated wear.

Between 2019 and 2021, Exactech observed early linear and volumetric wear in Connexion GXL liners implanted in .118% of patients between 3-6 years of their hip replacement surgery. The company notes that in “some of these patients, wear has led to proximal femoral and acetabular osteolysis.”

Patients experiencing any side effects from hip replacement surgery should contact their surgeon. 

For those who have experienced complications from Exactech Connexion GXL hip liners, the company has established means of compensation. Impacted patients have also consulted attorneys and explored their legal options, including filing lawsuits against Exactech, to obtain compensation for medical expenses, as well as pain and suffering.

Exactech’s hip simulator studies showed a 59% reduction in the wear rate.

However, two 2020 studies published in peer-reviewed medical journals found that the Exactech Connexion GXL liner may be prone to a high rate of early failure. Study authors concluded the failure rate was caused by high wear rates that led to osteolysis.

High Rate of Early Failure

Dr. W. Christian Thomas and colleagues at the University of Florida College of Medicine published their study findings in the Journal of Arthroplasty.

Authors looked at their institutional database for patients who had significant osteolysis after a primary hip replacement with an Exactech Connexion GXL liner from January 2009 to June 2019.

They identified 12 patients, and nine of them were undergoing revision surgery because of complications. They found the average time before the implants failed was 55.9 months, or about five years due to severe osteolysis and implant failure.

Authors did not find any patient risk factors or implant positioning, so they concluded it could be the implant’s design causing early failure.

“The Exactech Connexion GXL liner may be prone to a high rate of early failure from wear and severe secondary osteolysis. We recommend close surveillance of patients with this bearing surface,” authors concluded.

‘Catastrophic Early Polyethylene Wear’

Dr. Cynthia Kahlenberg and colleagues at the Hospital for Special Surgery published their review in Arthroplasty Today.

Authors looked at 204 total hip replacements performed by one surgeon using the Exactech Connexion GXL liner. They found five cases of osteolysis and severe wear that occurred within five years of surgery.

All five patients reported hip pain. X-rays found wear with osteolysis in the joints, and MRIs found inflammation.

“This review of 5 cases of catastrophic early polyethylene wear demonstrates a concerning trend with the use of the Exactech Connexion GXL liner,” authors concluded.

They recommended close monitoring and regular investigations of patients with this implant.