Medical device manufacturer Exactech has been making knee replacement components for a number of years now, servicing the growing market for joint replacement surgery that currently is a byproduct of aging Baby Boomers—once the largest living generation in history. This Gainesville, Florida based company has steadily grown into a global presence that provides bone and joint restoration products to patients worldwide, yet their story has been marred by problems; In 2010, the company settled with federal prosecutors for $3 million as a result of kickbacks given to orthopedic surgeons and in 2013, the company had a string of product recalls involving both hip and shoulder replacement devices due to incorrect and transposed product labeling.
As numerous FDA reports show, the problems might still continue with the premature failure of products manufactured under their “Optetrak” label—allegedly due to a finned tibial tray design that does not allow for adequate adherence to the patient’s bone—resulting in loosening, instability, pain and possible infection. Such failure could require revision surgery and device replacement, not to mention threatening the patient’s safety and quality of life. The problem could be significant, as more than 600,000 knee replacement surgeries are performed in the U.S. each year, a number that could grow to one million within the next 10 years.
One of the patients to have received an Optetrak knee replacement has now become the Plaintiff in a lawsuit recently filed by Childers, Schlueter & Smith, making it the first Optetrak case in Georgia and one of first ones filed throughout the U.S. In court documents filed on September 27, 2017, the Plaintiff alleges that Exactech not only designed, manufactured and sold a defective device, but also that the Defendants concealed knowledge of the defect and any risks or dangers from both patients and their doctors. Furthermore, the lawsuit alleges that the Plaintiff has suffered severe and permanent injuries from the Exactech Optetrak Knee as well as ongoing rehabilitation and medical care. If that is not damaging enough, failure of the Optetrak device is also believed to causea condition known as aseptic lymphocyte-dominated vasculitis-associated lesions (ALVAL) as well as metallosis—a condition where metal debris builds up in the body and can cause inflammation, synovitis and even the death of surrounding tissue and bone.
Most knee replacement surgeries should give the recipient years of improved function with fewer problems and less pain—but product failures do happen and often require correction, usually at the inconvenience and suffering of the patient. If you or a family member has experienced such issues or other complications from an Exactech Optetrak knee component, our law firm of Childers, Schlueter & Smith might be able to help as we continue to investigate the connection between premature knee failure and Exactech products. If you have questions, please give us a call at 1-800-641-0098 or email our Exatech knee lawyers at Info@cssfirm.com. All initial inquiries are free of charge and without obligation.
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer again in 2019, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys and a Top 100 Lawyer in Georgia by the National Trial Lawyers in 2019.