Following a series of medical device recalls that affected thousands of Exactech knee, hip, and ankle implants, a new product liability lawsuit alleges that the plaintiff underwent revision surgery to remove a failed Optetrak total knee replacement system that had led to her suffering a severe infection, only to receive another potentially faulty Optetrak knee implant. As such, the plaintiff, Minerva Salazar, is now concerned that she faces the same risk of premature failure with her new Optetrak device. If you or someone you love has suffered complications due to a failed Exactech knee, hip, or ankle implant, contact Consumer Safety Watch as soon as possible. You may have grounds to file a defective device lawsuit against Exactech, in order to pursue compensation for your injuries, medical expenses, and other damages.
Exactech has admitted that most of the polyethylene inserts that have been manufactured since 2004 and used in its hip, knee, and ankle replacement systems were packaged in out-of-specification vacuum bags that were were oxygen resistant but were missing a secondary layer containing ethylene vinyl alcohol meant to further augment oxygen resistance. “[These] polyethylene inserts cannot be exposed to oxygen during the packaging and storing process,” Minerva Salazar’s complaint states. “Exposing polyethylene inserts to oxygen creates a chemical reaction called oxidization, which causes the premature wear or degradation of polyethylene inserts.” Salazar joins a growing number of plaintiffs alleging that Exactech’s polyethylene components were packaged in non-conforming bags and may be susceptible to premature wear and early failure leading to the need for revision surgery.
Salazar’s lawsuit also alleges that Exactech knew or should have known as early as 2012 that its total knee arthroplasty (TKA) systems were failing at a higher than expected rate due to problems with its polyethylene components. Adverse event reports submitted to the Manufacturer and User Facility Device Experience (MAUDE) database up to that point described instances of TKA revision due to complications like “loose tibial component,” “polyethylene deformation,” and “pain, limited mobility, knee swelling and sensitivity” caused by loosening in the artificial joint. Despite these issues, Exactech continued to design, manufacture, and distribute its total knee replacement systems, without notifying surgeons or patients about the potential increased risk of premature failure.
Beginning in August 2021, Exactech began removing from the market certain TKA and total ankle arthroplasty (TAA) systems with defective polyethylene components. In February 2022, the manufacturer recalled more than 140,000 polyethylene inserts used in Optetrak, Optetrak Logic, and Truliant total knee replacement systems manufactured since 2004. The company issued a letter alerting healthcare professionals about the recall, indicating that “[W]e have confirmed that most of our inserts manufactured since 2004 were packaged in out-of-specification (referred to hereafter as ‘nonconforming’) vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.” Exactech warned in the letter that oxygen diffusion to the polyethylene inserts can “severely degrade” the inserts and “can lead to both accelerated wear debris production and bone loss, or component fatigue cracking/fracture, all leading to corrective revision surgery.”
Thousands of implant recipients who received Exactech devices that were subsequently recalled are now experiencing issues with their implants failing earlier than expected and undergoing revision surgery to remove or replace the failed implants. According to Minerva Salazar’s complaint, she was implanted with an Optetrak Logic Total Knee System in July 2017. The implant failed prematurely and led to her suffering a severe infection and requiring revision surgery. However, because healthcare providers had not yet been warned about the problems with the Optetrak knee replacement system, Salazar’s surgeon replaced the failed implant with another Optetrak knee system featuring the same polyethylene insert that is prone to early failure. If you received a recalled Exactech knee replacement device, and you have suffered complications like pain, swelling, implant loosening, instability of the replaced joint, bone loss, implant fracture, or the need for early revision surgery, contact Consumer Safety Watch to find out if you may be eligible to file a defective device claim against Exactech.
