Exactech Lawsuits Claim Defective Hip Implant

Santa Clara, CAA product liability lawsuit filed in the U.S. District Court for the Eastern District of Arkansas last month claims the Exactech Novation hip implant was defectively designed, which led to early failure of the hip replacement. And this month a similar lawsuit was filed in New York claiming that Exactech knew or should have known that the polyethylene liners in its hip replacements would prematurely loosen and fail, but delayed a recall.

At issue is the Exactech Connexion GXL Liner, which is made of irradiated ultra-high molecular weight polyethylene (UHMWPE). A hip liner is the component inserted into the artificial hip socket or cup that interfaces with the femoral head or ball. Exactech marketed its liners as having less wear and lasting longer than its competitors' polyethylene liners.  

In 2013, George Wilson underwent a total hip arthroplasty procedure, in which time he was implanted with an Exactech hip replacement that included the recalled and defective Connexion GXL polyethylene liner and other Exactech Novation Crown Cup components. Eight years later--and two months after Exactech Connexion GXL liners were recalled--he needed revision surgery after suffering severe and painful osteolysis, which is a progressive degeneration of the bone.

Charles Agro also underwent a total hip arthroplasty in 2013, which included the Exactech Connexion GXL liner. He too suffered premature osteolysis and experienced severe pain and discomfort, which led to revision surgery in September 2019. According to his lawsuit, Agro continues to experience severe pain and discomfort.

Exactech Hip Recall

Exactech issued a recall in late June 2021 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.  One month before the recall, Excactech 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.”

According to Charles Agro’s complaint, the Exactech Connexion GXL liner (referred to as the “ Product”) was removed from the market in 2019 due to 89,050 devices being impacted by premature wear.

Exactech Lawsuits

The lawsuits claim that the Exactech implant used during a routine total hip arthroplasty surgery was defectively designed, manufactured, marketed, and sold by Exactech because it contains a polyethylene liner prone to a high rate of early failure from wear, causing severe secondary osteolysis (bone degeneration).

Agro filed his lawsuit in the U.S. District Court for the Southern District of New York on March 15, 2022. According to his complaint, defendant Exactech obtained clearance by a 510(k) application in 2007, which allowed the company to bypass having the FDA or its experts evaluate its “irradiated ultra-high-molecular-weight polyethylene (UHMWPE) plastic in the Product”.

UHMWPE has been used clinically in joint implants due to its low friction, high wear resistance, good toughness, high impact strength, high resistance to corrosive chemicals, excellent biocompatibility, and low cost. However, there is an unacceptably low stability of oxidation of polyethylene. As a consequence, two stabilization strategies were developed and adopted in order to minimize post-irradiation oxidative ageing: one involved post-irradiation melting of the polyethylene (“remelting”), while the other included a thermal treatment, but at a temperature below complete melting of the crystallites (“annealing”). The rationale for the protocol was to eliminate or reduce an increased rate of oxidation of the polymer. The Product was neither remelted nor annealed, leading to its premature wear.

George 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, the Plaintiff 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. 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.