Exactech Knee Failure, a Texas-sized problem. They say that everything is bigger in Texas, and now a Texas-sized problem is coming to haunt Exactech Inc., the maker of the recalled Exactech knee implants.
Knee Implants is big business
Knee implant surgeries have exploded in the last few years, as baby boomers have developed mobility issues. Over 700,000 Americans annually undergo knee replacement procedures. Knee replacement can help relieve pain from joint trauma or degenerative disease like osteoarthritis. According to experts, the number of knee implants will likely quadruple over the next 10 years.
Patients undergoing knee implants have knees damaged from degenerative arthritis, traumatic injuries, or age-related wear and tear. Knee implant patients expect 15 to 20 years of future pain-free mobility.
Exactech Knee failure
A huge recall has begun for more than 140,000 Exactech knee implant replacement devices that were implanted in the United States since 2004, a Texas-sized problem to say the least. The Exactech knee implant replacement devices have a defectively packaged plastic insert made of polyethylene that may cause the knee implants to fail prematurely, resulting in the need for additional painful and expensive surgery. This plastic piece acts as a cushion, between the metal components of the new knee joint.
Exactech is a medical device manufacturer based in Gainesville, Florida, and now admits according to lawsuit allegations, that it has been selling defective knee implant replacement systems for almost twenty years, including Exactech Optetrak, Optetrak Logic, Truliant, and Vantage makes of knee implants.
The Exactech knee implant has problems
The Exactech Optetrak knee replacement system was first sold in the United States in 1994, and Exactech may have incorrectly packed the plastic polyethylene insert.
According to Exactech warning letters to the FDA and orthopedic doctors, “most of our inserts since 2004 were packaged in out-of-specification… vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.”
In other words, Exactech admits that this defective packaging allows the plastic inserts to be attacked by oxygen (air) before they are implanted, causing the component to developing microfractures and cracks leading to premature failure, or becoming damaged once implanted.
As a result of the Exactech knee failure, patients may develop severe knee pain, swelling or joint instability, pain in walking, or difficulty to weight bear. Some patients experiencing Exactech knee failure note knee grinding, and clicking, leading to knee revision surgery or procedures to replace the worn-out plastic polyethylene insert.
New York Lawsuit Filed Over Recalled Optetrak Polyethylene Liner
Recently, Leslie Liberatore, from New York, filed a product liability lawsuit in the U.S. District Court for the Southern District of New York, claiming that she received one of the defective Optetrak polyethylene liners, which failed prematurely and caused her to undergo revision surgery.
According to Liberatore, her Exactech Optetrak knee failed within seven years after implantation, leaving her with permanent and disabling injuries. Liberatore underwent bilateral total knee replacement surgery in 2012, with the Optetrak Logic Tibial plastic inserts. But, in early 2019, she required additional revision surgery after she developed loosening and bone loss in her left knee. She has now discovered the problems she experienced were a direct result of the defective packaging. Liberatore had expected her knee implants to last a lot longer.
Liberatore also had to undergo painful revision surgery involving her right knee implant for similar problems and failure findings in 2021.
Exactech Optetrak Knee Lawsuits
This case joins an enlarging pool of Exactech knee lawsuits, filed by knee implant patients who experienced problems with Optetrak, Optetrak logic, or Truliant implants. These lawsuits all share similar allegations, in that Exactech the knee implant maker, knew or should have known about the defects and warned about them much earlier.
Opetrak knee implant devices have performed poorly when compared to its competitors. The Australian Orthopaedic Association, an internationally recognized orthopedic implant registry, has identified the Optetrak as an implant with a higher-than-expected rate of revision.
These lawsuits allege that Exactech has been aware of a high rate of early failures associated with the Opetrak Device. By 2012, the company had further clinical evidence that Optetrak Devices were failing at a rate higher than promoted.
Reports in the Manufacturer and User Facility Device Experience (MAUDE) indicate instances of revision due to “loose tibial component”, “aseptic loosening”, “pain and visible loosening”, “polyethylene deformation”, “polyethylene worn”, and “pain, limited mobility, knee swelling and sensitivity” due to “loose” joint.
EXACTECH KNEE RECALL LAWSUITS. Did you or a loved one experience problems with an Exactech Optetrak, Optetrak Logic, or Truliant knee replacement? Dr. Shezad Malik law firm based in Dallas, Texas now reviewing Exactech knee implant failure and revision cases nationwide. Please call 214-390-3189 or email us for further information.
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