FDA Recall of Exactech GXL Hip Implant
Exactech GXL hip implant liners may be prone to a high rate of early failure, putting some patients at a higher risk of complications due to premature wear. After a number of adverse event reports indicated premature device failure, in June 2021, Exactech’s Connexion GXL acetabular polyethylene liners were recalled by the FDA. The Exactech liners were recalled after the company notified its sales agents of an increased risk of premature wear with the product. Prior to this notice, Exactech notified surgeons that the GXL had been phased out and replaced by a newer product. No mention was made of any pending recalls.
The recall stated patients who received these implants had an increased risk for premature wear and edge-loading of components. This can lead to device loosening and lack of mobility, severe pain, and osteolysis or death of bone tissue.
Exactech Lawsuit Filed in Florida Court Against Hip Manufacturer Over Recalled Connexion GXL Hip Liner Implant
The Nash & Franciskato Law Firm along with co-counsel are speaking with patients who received Exactech Connexion GXL implants and suffered injuries associated with excessive wear to the plastic liner insert leading to early device failure.
More than 90,000 hip replacements with the Exactech Connexion GXL liners were recalled in 2021. Lawsuits are now being filed against the company and are expected to grow significantly.
What are Hip Implant Liners?
Hip implant liners, also known as acetabular liners, are one of several parts of a complete hip implant. Made of plastic or ceramic, they often line the area between the ball of the hip socket and the cup it fits into to allow the implanted components to move freely and smoothly.
The Connexion GXL acetabular liner, manufactured by Exactech and made from a plastic called polyethylene, was designed to be used in total hip replacement surgeries (primary and revision) working with other Exactech brand hip replacement systems (Acumatch, MCS Systems and Novation). The liners are typically used for those who need a total hip replacement due to joint-degrading conditions such as osteoarthritis and rheumatoid arthritis, and bone damage resulting from trauma or disease.
Exactech marketed the Connexion GXL liner as being more resistant to wear and fracture; however, some studies have reported osteolysis in patients with the liner.
What is the problem with Exactech GXL Hip Implant Liners?
Success rates for hip replacement surgery are typically high; however, some patients implanted with the Exactech Connexion GXL Hip implant liner have suffered complications, including premature wear, that can cause serious damage to a person’s hip joint and result in the need for revision surgery.
According to research reports, Exactech’s GXL hip liners have been known to deteriorate earlier than expected due to a design flaw.
- Two studies reported concerns that the product was prone to early failure, which occurred an average of five years following the surgery and in some cases less than a year after being implanted.
- Exactech reports that early failure of the polyethylene liner appears to be more pronounced in patients with larger femoral heads paired with the thinnest available liner; in more active patients; and with a certain type of total hip replacement surgical approach.
Premature wear of the GXL acetabular liners has led to complications such as osteolysis, component loosening, tissue damage and other serious complications.
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Warning signs of product failure include:
- Hip pain
- Limited range of motion/mobility
- Difficulty walking
- Weakening or loosening of the joint
A serious complication that can develop, osteolysis, is a progressive condition where bone tissue is destroyed. In this process, bones lose minerals, soften and become weaker. One type of osteolysis can occur as a complication of joint replacement surgery. This is where polyethylene or other materials in a hip implant can wear down. Debris accumulates in the surrounding joint tissue and bone, which can lead to implant loosening and premature revision surgery.
Studies Raise Concerns
One study found the average time before the implants failed was 55.9 months (about 5 years). According to the authors, “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.”
The authors of both studies concluded it could be potential design flaws causing these problems with early wear.
Have you heard from your surgeon?
Exactech’s communication to surgeons recommended that GXL patients who are less than six years from index surgery and who have not been seen in over 12 months, return to their physician for a routine clinical exam and x-rays to properly evaluate the status of their implant.
When you have questions, we are here for you. Contact us at (877) 284-6600.
More Product Recalls for Exactech
On February 7, 2022, Exactech recalled more than 147,000 knee replacement systems and several hundred ankle replacements with polyethylene liners that can potentially lead to accelerated excessive wear, bone loss and failure requiring corrective surgery.
Have you received one of these systems?
- OPTETRAK® – 60,926 implants since 2004
- OPTETRAK Logic® – 60,518 implants since 2009
- TRULIANT® – 24,727 implants since 2017
- VANTAGE® – 1,561 implants since 2016
FREE CASE EVALUATION FROM DEDICATED, EXPERIENCED ATTORNEYS
It can be devastating when the medical devices you rely on fail. The Nash & Franciskato Law Firm has a proven track record against medical device manufacturers.
What we offer goes beyond experience. Our legal team is dedicated to you and helping you put your life back together, giving you:
- Over 80 years of combined experience
- Trusted legal advisor committed to your needs
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START YOUR FREE, CONFIDENTIAL EVALUATION WITH ONE OF OUR TEAM
If you have been advised to undergo a revision surgery, or have already had one, due to complications associated with the Exactech Connexion GXL hip implant liner, contact the law offices of Nash & Franciskato at (877) 284-6600. The time to request your free, no-obligation case review is today. We will review your case in a free and confidential consultation, with no risk or obligation to take legal action.