The Optetrak Total Knee Replacement system is only the latest in a growing list of prosthetic knee devices that are failing prematurely, causing patients excruciating pain and loss of mobility, requiring them to undergo complicated revision surgery. Furthermore, it is not the first time that manufacturer Exactech has faced legal problems in connection with its products and business practices.
The first Optetrak knee device was approved by the FDA in 1994. Since that time, the device has undergone a number of “revisions,” each of which was approved via the 510(k) Premarket Notification process. This meant that none of these updated products underwent any safety or reliability testing. Instead, Exactech was required only to demonstrate that the revisions were “substantially equivalent” to the previous models already on the market. One of the recent lawsuits filed against the company alleges that
“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...early onset failure mode reports are representative of the increased rate of incidents of which Defendants had become internally aware.”
In other words, Exactech was fully aware of the problems – or it should have been. According to the complaint, a number of reports had been made to the FDA's Manufacturer and User Facility Device Experience (MAUDE) system about loose components resulting in pain, reduced mobility and swelling.
It exhibits a pattern of corporate recidivism on the part of Exactech. In 2007, the company was the target of an investigation by the U.S. Attorney's Office after the Department of Health and Human Services filed a criminal complaint, charging Exactech with violations of federal anti-kickback statutes.
Between January 2002 and the end of 2008, Exactech essentially bribed physicians using “consulting agreements” that were “designed and implemented, in part, to induce the surgeons to use, and cause the purchase of, Exactech’s… products.” The company ultimately settled with the Department of Justice in 2010 for $3 million.
Less than three years later, a number of Exactech hip and shoulder replacements were subject to recall because they had been improperly labeled.
Over the past several weeks, the first lawsuits have been filed against the company, alleging that Exactech knowingly designed, manufactured and marketed a product it knew to be defective and concealed that information from physicians and consumers.
In addition to debilitating pain and the need for additional surgeries, there is evidence that the Opetrak Knee Replacement's failures are causing metallosis, the result of metal shards building up in the body causing inflammation and necrosis of the tissues. Another health-related condition that may be attributed to these device failures is known as aseptic lymphocyte-dominated vasculitis-associated lesions (ALVAL). This is a tissue reaction that also results from exposure to metal, in which surrounding tissues begin to form tumor-like masses.
Opetrak litigation is just now getting underway, but with well over half a million knee replacements being performed in the U.S. on an annual basis, chances are good that Exactech will be swamped with lawsuits in the coming months.