EXACTECH CONNEXION GXL HIP REPLACEMENT LINER
Urgent Exactech Recall – Exactech Hip Replacement Lawsuit
Exactech, a Florida-based medical device manufacturer, has issued an FDA recall for several medical devices. The recall list includes Optetrak, Optetrak Logic, Truliant knee replacement products, Vantage ankle replacement products, and the Connexion GXL Hip Liner. The recall is prompted by the plastic in these products wearing out much faster than expected, causing the devices to fail.
Most of these products were marketed to last 15 to 20 years but are failing much earlier. The failure leads to pain and complications that usually require additional revision surgery to correct the problems caused by these defective products. Lawsuits are being filed for victims injured by the recalled products.
“Enhanced” Polyethylene Wears Out Causing Bone Damage and Potential Hip Replacement”
Exactech uses a special type of polyethylene in its products known as UHMWPE (Ultra High Molecular Weight Polyethylene). Exactech claimed that this “enhanced polyethylene” enabled its products to wear less and last longer than the standard polyethylene used by other orthopedic implant manufacturers. The opposite has proven true.
The industry standard for orthopedic implants is cross-linked polyethylene. Cross-linked plastic is treated with gamma or electron beam irradiation to create harder, stronger, and more wear-resistant plastic. Vitamin E was added to the material in the mid-2000s, further improving hip liner longevity. This design has been patented, leading some manufacturers, such as Exactech to design their version of this plastic to avoid paying patent fees.
This is where Exactech’s Ultra High Molecular Weight Polyethylene comes into play. Exactech created this as a way of saving money. However, due to poor manufacturing, the resulting polyethylene was not treated like the patented cross-linked polyethylene during production. This resulted in free radicals on the surface of the plastic, making it more susceptible to oxidation.
Exactech claimed that the packaging the product was in caused the early oxidation. However, the product is meant to resist oxidation since it will still encounter oxygen while implanted inside the body. The failure of this plastic, and by association- Exactech’s failed products, result from cutting corners to save money. This could have been avoided had Exactech used the patented cross-linked polyethylene that has proven highly successful in orthopedic implants. Instead, countless individuals suffered harm and had to undergo a hip replacement simply to save the company a couple of bucks.
Exactech Connexion GXL Hip liner
Exactech’s Connexion GXL hip implant is a medical device used in total hip replacements. It is a “metal on plastic” hip implant featuring an acetabular liner made of polyethylene plastic. These implants are failing due to the deterioration of the polyethylene liners. The deterioration exposes the metal, causing the metal components within the implant to rub together and break down prematurely.
Studies by orthopedic surgeons of the Exactech Connexion GXL liner published in medical journals have shown that this defective liner is prone to early failure. When the plastic wears out, it causes severe bone damage called osteolysis, often requiring hip liner replacement surgery.
Symptoms of the Device Failure include:
- Difficulty walking
- Loosening of the implant
- Joint Stiffness
- Swelling and inflammation
- Possible bone degeneration: osteolysis
- Extreme Pain
High Failure Rates Lead to FDA Recall
In June 2021, Exactech finally recalled the Connexion GXL liner because of the medical community’s concerns about its high failure rates from wear, which caused severe osteolysis.
This recall affected roughly 90,000 patients with the Connexion GXL Liner. Exactech also sent doctors an “urgent communication” warning about the higher failure rates. Exactech recommended that Connexion GXL patients follow up with their doctor if they have received their hip implant in the last six years and have not had a follow-up appointment in the past 12 months.
Exactech Attempts to Limit Rights of Patients
Following the recall, Exact hired the company Broadspire to contact individuals with their recalled products to see if they had complications and would need revision surgery. For those suffering from complications, Broadspire offers compensation, but only to cover the cost of the revision surgery.
In exchange for compensation, these individuals must waive their rights to any future legal action against Exactech, preventing them from recovering payment for the pain and suffering they have experienced.
Exactech hired Broadspire to save the company money. They are looking out for Exactech, not persons harmed by the device.
If you have any recalled Exactech products and are suffering from complications, DO NOT sign an agreement with Broadspire. Doing so will waive your right to claim total compensation for the pain and suffering caused by this Exactech defective product.
Latest Updates on Exactech Hip Liner Lawsuits
Important Update October 29, 2024: Exactech filed for Chapter 11 bankruptcy on October 29, 2024. This places an automatic stay on all legal actions against Exactech while the bankruptcy court assesses Exactech’s financial situation. All discovery has ceased, and upcoming bellwether trial dates have been canceled. The Broadspire financial program is also no longer in effect. While this new development will delay our ability to obtain compensation for your injuries, it should not be a permanent impediment. Thus, we are still accepting all viable Exactech cases.
This is a developing issue, subject to additional rulings by the bankruptcy court and MDL leadership. We will continue to provide updates as they become available.
As of September 2024, the U.S. District Court for the Eastern District of New York is handling 1,670 pending lawsuits in multidistrict litigation (MDL), overseen by Judge Nicholas G. Garaufis. No bellwether trials have occurred yet, but they are scheduled to begin in July 2025. The lawsuits are still in their early stages, and the number is growing as more cases are being taken on by attorneys.
August 2024: The commencement of the initial bellwether trials in the MDL has been moderately postponed, with each now rescheduled over a month later than originally planned. During a status conference, discussions arose concerning ongoing discovery disputes before proposing new trial dates. Gayle Tarloff’s trial is rescheduled to begin on July 6, 2025, while Geraldine Larson’s trial is now set for September 29, 2025. These trials were initially slated for June and August of that year.
May 2024: The defendants chose David Caputo (1:23-cv-01896-NGG-MMH) as the preferred option from the National Pool for the fourth bellwether test trial, slated to commence in January 2025. Jury selection for this trial might begin in January 2026. Meanwhile, the third bellwether trial, involving Dana Kessler Kramer, is scheduled to start in October 2024, with jury selection planned for October 2025.
April 2024: Judge Garaufis has scheduled the initial bellwether trials for June 2025 (Gayle Tarloff) and August 2025 (Geraldine Larson).
March 2024: Exactech has voluntarily recalled its Equinoxe reverse total shoulder (rTSA) and anatomic total shoulder (aTSA) devices. This decision follows an FDA recommendation to remove the devices to prevent market confusion or concern.
January 2024: The FDA has announced a recall of an unspecified number of AcuMatch Hip System units by Exactech due to reports of vacuum loss in the inner vacuum bag of four devices. This Class 2 recall affects devices distributed in the U.S. and 12 other countries.
January 2024: A status conference for the Exactech class action MDL was scheduled for March 13, 2024, to address the current litigation status, unresolved discovery issues, and the selection of bellwether cases.
December 2023: Parties involved in the New York MDL and Exactech litigation in Florida were selecting bellwether test trials. They planned to discuss the MDL bellwether plan by the end of the month.
You May Have a Claim for Compensation
If you or a loved one has been implanted with any of the recalled Exactech products or underwent a hip replacement due to a defective Exactech product, call 1-800-Yost-Law.
Our hip replacement lawyers at The Yost Legal Group will speak with you for free and answer any questions you have.
Call us today at 1-800-YOST-LAW (1-800-967-8529) for a free consultation, or email us at info@yostlaw.com. Our experienced Exactech lawyers can help you pursue your Exactech claim. We are investigating claims for individuals who are seeking Exactech settlements. There is no fee or expense unless you recover.
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