National Knee Replacement Failure Attorneys
Each year, approximately 700,000 Americans undergo knee replacement surgery. Recent studies and adverse event reporting indicate that a popular replacement device, the Exactech Optetrak (“Optetrak”), is associated with early failure due to debonding of the tibial tray and catastrophic polyethylene wear.
Dating back to 2008, Exactech learned that some patients were experiencing early failure of the Optetrak knee implant requiring revision surgery. Rather than recall the device from the market, Exactech quietly redesigned the Optetrak knee implant in an effort to correct the problems but failed to warn orthopedic surgeons about this serious health risk.
The Exactech Optetrak Knee System
The Optetrak knee replacement system is manufactured by Exactech, Inc. The device was first cleared for marketing via the FDA’s “fast-track” 510(k) process in 1994.
Under the 510(k) process, a manufacturer is not required to conduct clinical trials of the medical device it intends to market. Instead, the company must only demonstrate that the new medical device is substantially similar to an older model before it can be sold and implanted into patients.
Failure of the Optetrak Knee Implant
The failure of the Optetrak knee implant has been attributed, in part, to a finned tibial tray which may not adequately adhere to surgical cement and, therefore, be unable to withstand the stress placed on the joint during normal use. This “debonding” of the tibial tray can lead to loosening of the component and the need for revision surgery.
Exactech became aware of the high early failure rate with the Optetrak knee implant as far back as April 2008. Beginning by at least 2011, the FDA began receiving complaints about the Optetrak knee replacement device failing. Around this time, Exactech began designing a new tibial tray with the hope that it would correct the problem.
In 2012, Exactech realized that the rate of finned tibial tray failure with the Optetrak knee implant was increasing. In 2013, Exactech changed the design of the Optetrak knee implant to a “fit” tibial tray, which may achieve better long-term results than the prior finned tibial tray. At this same time, rather than formally recalling the device, Exactech began replacing the finned tibial trays with the new design without alerting physicians about the real reason for the change.
In addition to tibial tray loosening, increasing adverse event reporting demonstrates that the Optetrak knee is also prone to early failure due to polyethylene wear. Polyethylene wear occurs when the plastic liner placed between the femoral and tibial components is worn away or ground through due to the compression forces placed on the device during routine use. In many cases, sections of the polyethylene insert have been shown to be completely disintegrated only a few years after implantation.
Optetrak Knee Implant Injuries
When a knee implant fails, significant complications can occur. Some of these complications can take place years after the initial surgery. The Opetrak knee implant has been linked to serious injuries including:
- Swelling and inflammation
- Revision surgery
- Loss of mobility and range of motion
- Gait impairment
Exactech Optetrak Knee Implant Litigation
In 2017, the first of what will likely be numerous Optetrak knee implant lawsuits was filed against Exactech, Inc.
Plaintiffs allege that the Optetrak knee implant is defectively designed because of its propensity to loosen requiring the need for revision surgery. Plaintiffs also allege that Exactech failed to adequately warn orthopedic surgeon and patients about this risk. Plaintiffs further allege that Exactech did not properly or thoroughly test the Optetrak knee implant before it was put onto the market.
Optetrak Knee Replacement Lawsuit
If you or someone you love has suffered injury from an Exactech Optetrak knee implant or another artificial knee device, you may be entitled to significant compensation for your injuries.
To speak with an experienced, knee implant lawyer, contact Fitzgerald Law Group at (844) FITZ-LAW or (844) 348-9529, or complete the Case Evaluation Form on this website for a free, confidential, case assessment.