Robins Kaplan LLP is examining the recent recall of orthopedic devices that were manufactured by Exactech for hip, knee, and ankle implants. Since 2021, Exactech has recalled approximately 185,000 devices with the latest recall just issued on August 11, 2022. A multidistrict litigation petition was filed on June 14, 2022, and Robins Kaplan has begun filing cases across the country and on behalf of patients who are affected by the Exactech recalled devices.
The recall first became public in February 2022 when Exactech issued an Urgent Medical Device Correction Notice informing surgeons that most of the Exactech knee inserts that were manufactured from 2004 until 2022, contained nonconforming packaging layers on the ultra-high-molecular-weight polyethylene (UHMWPE) components. Specifically, the packaging layers for the plastic insert allow a large amount of oxygen to diffuse into the insert while it is being stored and before it is implanted, which can lead to a process called oxidation.
As part of the same February 2022 notice, Exactech recalled its total ankle replacement devices that were manufactured between the years of 2017 and 2022. Like the knee recall, the polyethylene (plastic) insert that fit between the tibial component and the talar component as the new cushion or cartilage for the replaced ankle joint, contained the same defect that allowed the plastic to become oxidized, which can cause the plastic to wear out prematurely or to become damaged after it is implanted into the patient’s body.
Recalled devices include the following Exactech knee and ankle systems:
- Optetrak: 60,926 implanted units since 2004
- Optetrak Logic: 60,518 implanted units since 2004
- Truliant Knee Replacement: 24,727 implanted units since 2004
- Vantage Ankle Implants: 1,561 implanted since 2004
Exactech also recalled around 90,000 hip replacements with Exactech Connexion GXL Liners in June 2021, because the plastic is manufactured using a “moderate” cross-linking process, which is inherently more susceptible to oxidation and premature wear that leads to bone loss/osteolysis. On August 11, 2022, this recall was expanded after Exactech identified the same defect in the packaging of the plastic liners causing increased oxidation of the plastic layers, and ultimately for the patient, leading to accelerated wear and bone loss and component fatigue cracking/fracturing. This additional recall expanded the recalled hip devices from 2015 back to as early as 2004, bringing the total number of Exactech recalled hip devices to approximately 125,000.
Because of these defects, some patients have required revision surgery to remove the failed plastic insert as well as other components of these devices. Degradation of the polyethylene alone, and potentially in conjunction with any other design issues, results in component loosening, tissue damage, osteolysis, permanent bone loss, and other injuries, leading to complex revision surgeries and extensive recovery time.
Patients who underwent total hip, knee, and ankle replacement surgeries in the following locations, but not limited to these locations, may be affected:
- Minnesota
- Gainesville, Florida
- New York City, New York
- Northern New Jersey
- Wisconsin
- Connecticut
- Ohio
- Raleigh, North Carolina
Unfortunately, Exactech has not yet directly notified individuals that their products are recalled, but instead are relying on surgeons to tell their patients whether they are impacted by the defective devices.
Our nationally recognized mass tort attorneys assist clients who are injured by dangerous and defective products, and we are available to evaluate your potential claim against the manufacturers of Exactech. If you have a potential client who is impacted by the recall, please contact Rayna Kessler at 212.980.7431 or RKessler@RobinsKaplan.com.
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