What You Need to Know About Exactech Hip Implant Failure

It is widely accepted that a hip implant will last at least 10-15 years without requiring any revision surgeries. A recent study estimated that over 70% of hip implants have a lifespan of at least 20 years. So when hip replacement components start to show early wear, not only will the patient likely require revision surgery, but they are also put at risk for bone loss, infection, and injury.

In June 2021, global medical device manufacturer Exactech, Inc., issued a recall for almost 90,000 Connexion GXL Liners that have been used in hip replacement surgeries since 2008. Increased incidence of implant failures, often resulting in serious injury, prompted the recall. In this article, you’ll learn about:

  • The Exactech hip implant device in question
  • The studies that showed evidence of early wear
  • Exactech’s response to the evidence
  • What you can do if you think you have a case against Exactech

Terms to Know

THA: Hip surgery where damaged bone and cartilage are removed and replaced by a prosthetic implant

Osteolysis: A progressive condition in which bone tissue is destroyed, which can lead to further injury

Class II Recall: A type of recall administered by the FDA when a product may cause adverse health consequences

About the Exactech Connexion GXL Liner

Total hip arthroplasty, or THA, is a surgery that requires the implantation of four main components: shell, femoral head, stem, and liner. The shell (see image below) is a metal cup placed into the patient’s hip socket. The femoral head and stem fit into the shell in the hip socket. The liner is placed into the cup-shaped shell to provide a ball-and-socket joint that allows for movement similar to a natural hip.

The liner used in THA implants must last as long as the other components to avoid implant failure.

Exactech’s Connexion GXL Liner is a “moderately cross-linked” liner made from polyethylene, the plastic most commonly used in liners for THA. Cross-linking is intended to prevent wear and increase the lifespan of the liner, benefits that Exactech highlighted to market the product. These liners were designed for use in the Exactech Novation, Acumatch, and MCS hip implant systems and have been used in hip replacement surgery nationwide.

The Problems with the Connexion GXL Liner

March 2020 Study: “Unusual Early Excessive Wear”

In March 2020, researchers published a study in Arthroplasty Today[1], in which they reviewed 204 THA procedures performed by a New York surgeon using the Exactech Connexion GXL Liner. They identified five cases of severe polyethylene wear and osteolysis within five years of the THA surgery. The Exactech liner exhibited “unusual early excessive polyethylene wear,” despite the ordinarily “excellent long-term wear properties” of modern THA polyethylene components.

The faster rate of wear on Exactech liners causes patients to suffer implant failure during the first five years, which represents a stark deviation from the expected lifespan of modern hip implants.

The study confirmed all devices were implanted properly and found no patient risk factors for early implant failure (other than high activity level). Having ruled out these external possible causes, the authors noted their belief that “there may have been a variation in the processing of at least a batch of Exactech GXL liners that created a predisposition for early wear.” These findings demonstrated a “concerning trend with the use of the Exactech Connexion GXL Liner” and were reported to Exactech.

May 2020 Study: “Severe Secondary Osteolysis”

In the May 2020 issue of The Journal of Arthroplasty[2], researchers reviewed the University of Florida College of Medicine’s database for all cases of patients who presented osteolysis after surgery with Exactech’s Connexion GXL Liner. The case review, spanning January 2009 to June 2019, identified 12 patients presenting significant osteolysis, nine of whom had undergone revision surgery. The study also noted 22 reported cases of wear-related implant failure from 2009 to 2019 on the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

The case review identified 12 patients presenting significant osteolysis, nine of which had undergone revision surgery . . . the study concluded that the Exactech Connexion GXL liner may be prone to a “high rate of early failure from wear and severe secondary osteolysis.”

Of the patients with significant osteolysis, the average time it took to diagnose implant failure was approximately 4.5 years. Consistent with the New York study, the Florida study identified no “risk factors related to patient demographics or implant position.” Given the absence of notable external causes, the study concluded that the Exactech Connexion GXL liner may be prone to a “high rate of early failure from wear and severe secondary osteolysis.” The authors recommended “close surveillance” of patients with these liners.

Why It Matters

Studies conducted on the Exactech GXL Liner found that the faster rate of wear causes patients to suffer implant failure during the first five years following their initial surgery, which represents a stark deviation from the expected lifespan of modern hip implants. This unacceptable rate of breakdown in the Exactech GXL Liner causes significant injury to the patients and necessitates a painful and costly revision surgery. Patients undergoing major surgery such as THA want to be assured that the risk and physical and monetary burdens are worth it.

You May Have A Right To Compensation

Learn about our active lawsuit against Exactech.

Did Exactech Manage This Problem Responsibly?

According to their article, the authors of the New York study reported their findings to Exactech. Yet Exactech failed to take meaningful action until months later. Follow the timeline of Exactech's response below.
June 24, 2021: Exactech Contacts Sales Agents & Surgeons
On June 24, 2021, Exactech sent a letter to sales agents and surgeons stating that Exactech opted to “transition” GXL liners out of the market in favor of the XLE liner in 2019. Unlike the recalled GXL liner, the XLE liner is highly cross-linked and infused with Vitamin E, which has been shown to decrease the wear rate of liners. The letter also acknowledged that XLE liners had superior wear resistance compared to the GXL liners. Exactech asserted they were not recalling the GXL liner and stated that the GXL liner is “safe and effective and performs as intended.”[1]
June 28, 2021: Exactech Warns About Liner Showing Premature Wear
Days after stating there were no issues with the Connexion GXL Liner, Exactech sent an “urgent” letter to healthcare professionals explaining the GXL Liner’s premature wear and risk of osteolysis. The FDA subsequently investigated the early implant failures related to Exactech’s GXL liner and issued a Class II Recall on July 22, 2021.
August 26, 2021: Exactech Releases Urgent Field Safety Notice
According to Exactech’s Urgent Field Safety Notice from August 26, 2021, the company became aware of the studies conducted on the GXL Liner as early as nine months prior to notifying implanting surgeons. Yet Exactech failed to take any noticeable action until June 2021.

Do I Have A Case?

Most people do not know the specific devices implanted during their hip replacement surgery, but it is worth finding out. If you have suffered serious injury or undergone a revision surgery after THA with an Exactech GXL Liner, you may be entitled to compensation.

Pope McGlamry has been litigating defective orthopedic implant cases for more than a decade. We have represented thousands of clients nationwide and we are currently leading litigation against other defective implant manufacturers, including Microport, Stryker, and Wright Medical. If you or a loved one suffered serious injury or required revision surgery as a result of a defective Exactech Connexion GXL Liner, contact us by calling (404) 523-7706 or filling out the form below for a free case evaluation.

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