November 1, 2017 — A man from Alabama who needed revision surgery because his Exactech Optetrak® knee replacement failed prematurely has filed a lawsuit.
The lawsuit accuses Exactech Inc. of selling a defective medical device and engaging in a “silent recall” by removing Optetrak’s problematic finned tibial trays with sturdier “fit” tibial trays.
Many people have required revision surgery because the Optetrak loosened and failed prematurely, resulting in pain, limited mobility, knee swelling, and sensitivity due to loosening of the knee joint.
According to the Lawsuit (PDF):
“Despite Defendants knowledge of early onset failures of the Optetrak knee implants and the increased risk of failure for overweight and obese patients, Defendants never alerted the FDA of the known increased risks.”
The Optetrak has been sold since 1994, but in 2011 and 2012, Exactech added “fins” to the tibial tray component of the knee implant. Unfortunately, studies soon linked the “finned” tibial trays with higher rates of loosening and other problems that required revision surgery.
For example, a study of 110 patients with the Optetrak knee implant warned about “poor results” and high failure rates. The researchers found that 12% of patients needed revision surgery within 5 years, 20% needed routine painkillers, and another 22% were “evolving toward tibial implant loosening.”
The FDA approved all of the different versions of the Optetrak knee replacement through the 510(k) approval process, which means they did not go through extensive safety testing because they were “substantially equivalent” to other knee implants on the market.
The lawsuit was filed in the U.S. District Court for the Northern District of Alabama on October 11, 2017 — In RE: Marcus H. Talley v. Exactech Inc. — Case No. 2:17-cv-01735-RDP
Do I have a Knee Replacement Failure Lawsuit?
The Schmidt Firm, PLLC is currently accepting Exactech Opterak® knee induced injury cases in all 50 states. If you or somebody you know required revisions surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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