Attorney Kirk Pope has filed several Exactech hip recall lawsuits for his clients who have required hip replacement revision surgery.
Atlanta, GASince attorney Kirk Pope filed in federal court an Exactech class-action lawsuit against the orthopedic device manufacturer alleging its hip implant is defective, his civil litigation law firm Pope McGlamry is working with more clients who have had their Exactech hip recalled. “I have several clients who needed revision surgery—they have suffered terribly due to Exactech’s failure,” says attorney Pope. Their defective hip implant lawsuits claim that the Exactech implant used during a routine total hip arthroplasty surgery was defectively designed, manufactured, marketed, and sold by Exactech.
Exactech Hip Replacement Federal Lawsuit
In February 2021, Pope filed the class action lawsuit in Arkansas on behalf of his client George Wilson. “Exactech’s hip implant failed because it contains a polyethylene liner prone to a high rate of early failure from wear, which causes severe secondary osteolysis or bone degeneration,” explains Pope. “Mr. Wilson had a total hip replacement surgery in 2013. He was implanted with several Exactech artificial components, including the Novation Crown Cup Connexion GXL Line. Less than eight years after surgery, he suffered pain and severe osteolysis and required revision surgery.”
Wilson’s lawsuit states that Exactech acted negligently, that its implant has design and manufacturing defects, and that Exactech failed to warn doctors and consumers about the unreasonable risk of harm of the device. Additionally, Wilson alleges Exactech negligently made misrepresentations about the 59% reduced wear rate for the Connexion GXL polyethylene liner and that it had "enhanced polyethylene" with a lower wear rate. (A hip liner is a component inserted into the artificial hip socket or cup that interfaces with the femoral head or ball.)
As well, George and Valerie Wilson are claiming loss of consortium.
The case was filed in the United States District Court for the Eastern District of Arkansas, Wilson et al. v. Exactech, Inc., Case No. 4:22-CV-136-BRW.
Exactech Recalls
Around the same time as Wilson’s revision surgery, Exactech issued a recall for some models of its knee, ankle and hip polyethylene liners after concerns from the medical community that the polyethylene liner was prone to a high rate of early failure from wear and severe secondary osteolysis. Five days later, Exactech issued a recall for almost 90,000 Connexion GXL liners that have been used in hip replacement surgeries since 2008.
Shifting the Blame
One month before the recall, Exactech notified surgeons that issues had been observed and the GXL liners had been transitioned entirely out of the US market. Specifically, the orthopedic device manufacturer said, “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.” Does this sound like Exactech is trying to shift the blame to the surgeon? Pope believes that Exactech is also trying to shift the blame on its packaging supplier.
Packaging Issue
One issue is the expiration date, which should be no more than five years. “Exactech extended its hip replacement device to eight years with the understanding that it has proper packaging, i.e., a total oxygen barrier so that no oxidative process takes place,” says Pope. “But this extended shelf life is not recognized in the medical device industry and we don’t know the average shelf life – it could be defective at any age.
“We don’t believe the defect is just a packaging issue but Exactech is trying to blame Hillman Janitorial Supplies,” adds Pope. “The idea was that Hillman was to certify that its packaging conformed to these devices but it took a long time for Exactech to identify this as a problem, that quality control was not up to snuff. And because the problem wasn’t identified for years, it’s hard to say how long Exactech knew its device was defective.”
Studies conducted on Exactech’s Connexion GXL Liner (as early as 2020) found that the liner used in three different hip systems exhibited unusual” early excessive polyethylene wear.” Researchers found that 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 15-20 years-- the expected lifespan of modern hip implants. “To help degradation and increase the lifespan of the liner, manufacturers employ a process called “cross-linking”; highly cross-linked polyethylene is shown to be especially resistant to wear,” explains Pope. “One of the reasons that Exactech’s liner may have shown accelerated wear is because those liners were only ‘moderately cross-linked’”.
Exactcech distributed improperly packaged (and therefore compromised) devices that were never validated or properly tested.
In promoting its Exactech Hip Devices to surgeons, Exactech, knowing them to be false, made the following misrepresentations. a. Connexion GXL has robust wear resistance and fracture resistance properties as evidenced by bench testing and large long-term clinical follow-up series. b. The GXL liner UHMWPE undergoes two precision split-doses of 25kGy irradiation for a total of 50kGy. c. All Exactech acetabular liners (including all UHMWPE components) are vacuum packaged in sterile-barrier packaging materials to maintain oxidative stability in storage until implantation.
Exactach stated that, “prior to packaging, our parts are inspected again to ensure that they are within approved specifications. Packaged finished parts are then made sterile and ready for surgery through gamma irradiation performed by an outside vendor.”
Exactech knew of the associated consequences of vacuum sealing and oxidation, yet did no testing and implemented no quality control sampling during the lifetime of its Hip, Knee, and Ankle Devices to ensure that oxidation was prevented.
Exactech had packaging specifications in place that required the UHMWPE components of its Hip, Knee, and Ankle Devices be packaged in vacuum bags consisting of layers of low-density polyethylene, nylon, and an ethylene vinyl alcohol (“EVOH”) barrier to protect against oxidation.
Without the EVOH layer, oxygen is transmitted to the UHMWPE and degrades the mechanical properties of the material.
Exactech purchased the vacuum bags that were intended to contain an EVOH layer from a local Florida supplier, Hillman Supply, Inc. (On its website, Hillman Supply describes itself as a “stocking distributor of janitorial products, packaging materials, personal protection items, facility, supplies, and much more.” )
Exactech in its recall indicates that it discovered that Hillman provided the wrong packaging for seventeen years, and Exactech failed to recognize this deficiency for seventeen years … leading to hundreds of thousands of Exactech Devices being manufactured with improper packaging.”
“These Exactech hip replacements are a very bad failure, resulting in horrific bone loss,” says Pope. “Exactech changed the design of the hip liner in 2018 and didn’t recall the product for this packing issue so it’s safe to say they knew in 2018 that the device was defective. As for litigation, a schedule is in place and we are in the initial stages of discovery – we have served the original discovery to Exactech and now they have to produce…”
Kirk Pope and attorneys at Pope McGlamry have been litigating defective medical device cases for over a decade. They have led the way in defective orthopedic implant litigation, serving on leadership in litigations against manufacturers including Biotech, DePuy, Microport, Stryker, and Wright, and have represented thousands of clients across the country. Kirk Pope knows the intricacies of these types of devices and the mechanisms of failure, and more importantly, he understands the immense impact these faulty devices can have on the individuals (and their loved ones) who receive them.
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