Following a series of recalls that removed from the market thousands of hip, knee, and ankle replacement systems equipped with faulty polyethylene components, Exactech has recalled another 40,000 medical devices that may be defective and prone to early failure. In an urgent letter sent to surgeons, hospitals, and healthcare providers on August 11, 2022, the manufacturer reveals that it has identified an additional risk factor for premature wear affecting Exactech Connexion GXL and other polyethylene acetabular hip liners manufactured since 2004. Recipients of recalled Exactech implants may be at risk for bone loss, revision surgery, and other painful and debilitating device complications. If you were implanted with a recalled Exactech hip, knee, or ankle device that deteriorated and failed earlier than expected, contact Consumer Safety Watch today to find out how we can help.
After receiving reports of premature implant failure and high rates of early revision surgery among recipients of its Connexion GXL acetabular liners, Exactech in June 2021 issued a worldwide Urgent Dear Healthcare Professional (DHCP) communication informing surgeons that it had observed a higher-than-expected number of cases in which the Connexion GXL liner exhibited “early linear and volumetric wear” leading to “proximal femoral and acetabular osteolysis.” Osteolysis is a progressive bone degeneration condition in which the bones lose minerals, soften, and become weaker, sometimes as a complication of joint replacement surgery. In people with artificial implants, polyethylene components or other materials can wear down, causing debris to accumulate in the surrounding joint tissue. This can lead to inflammation and degeneration of the bone. Exactech noted in its June 2021 communication that nearly 90,000 Connexion GXL acetabular liners had been implanted in patients worldwide since 2008 and that these devices may be prone to premature wear and osteolysis.
In February 2022, Exactech expanded its initial device recall to include more than 147,000 Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts that were packaged in out-of-specification vacuum bags. According to the manufacturer, most of its polyethylene inserts manufactured since 2004 were packaged in non-conforming vacuum bags that were oxygen resistant but did not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH), which is meant to further augment oxygen resistance. “The use of these non-conforming bags may enable increased oxygen diffusion to the […] insert, resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer,” the letter to surgeons states. “Over time, oxidation can severely degrade the mechanical properties of conventional UHMWPE, which, in conjunction with other surgical factors, can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”
In the DHCP communication Exactech issued just this month, the company admits to having found a similar packaging problem affecting its Connexion GXL hip liners, which were initially recalled in 2021, in addition to other conventional (i.e. non-crosslinked) ultra-high molecular weight polyethylene acetabular liners manufactured since 2004. According to Exactech, more than 40,000 Connexion GXL moderately cross-linked polyethylene and conventional UHMWPE acetabular hip liners sold in the U.S. were also packaged in out-of-specification vacuum bags that exposed the inserts to oxygen prior to surgery. As a result of this faulty packaging, “these liners are susceptible to increased oxygen diffusion during shelf storage, with subsequent risks for component fatigue and damage after implantation,” the manufacturer warns. In other words, patients implanted with the recalled hip implants may be at risk for premature device failure resulting in the need for early corrective surgery. The devices affected by the expanded device recall include:
This latest device recall from Exactech comes as the U.S. Judicial Panel on Multidistrict Litigation (JPML) is considering a request to consolidate all Exactech knee implant lawsuits and Exactech hip implant lawsuits filed in federal courts across the country before one judge. The product liability lawsuits brought against Exactech all raise similar complaints regarding the use of defective polyethylene inserts and subsequent complications like pain, swelling, bone loss, instability of the joint, implant loosening, implant fracture, and early revision surgery. To learn more about Exactech’s hip, knee, and ankle implant recalls, or to find out if you may be eligible for compensation for defective device-related injuries, contact Consumer Safety Watch as soon as possible.