Optetrak Knee Replacement Lawsuit

Filing an Optetrak Knee Replacement Lawsuit may be an option for patients who were forced to undergo knee revision surgery due to the premature failure of this device following a 2011 or later total knee replacement procedure.

Contact an Optetrak Knee Replacement Lawyer Today

The nationwide law firm of Bernstein Liebhard LLP is offering free, no-obligation legal reviews to anyone who suffered serious complications related to the early failure of an Optetrak knee implant. To learn more, please contact our Optetrak Knee Replacement lawyers by calling (888) 994-5118.

Optetrak Knee Replacement: What’s the Problem?

The Optetrak Knee Replacement system was developed and marketed by Exactech, Inc., which initially obtained U.S. Food & Drug Administration (FDA) approval for the implants in 1994.

While the first Optetrak Knee was brought to market via the agency’s stringent premarket approval process, subsequent versions have been cleared through the FDA’s 510(k) program. 510(k) clearances do not require a device maker to conduct human clinical trials when it can be shown that a new product is “substantially equivalent” to a predicate device that has already undergone the standard premarket approval process.

A knee implant should last around 15 years. However, a growing number of Optetrak Knee Replacement lawsuits allege that versions manufactured in 2011 and 2012 are defective and prone to premature failure. These models featured a “finned” tibial tray, which purportedly fails to promote adequate adherence to surgical cement.

Among other things, Optetrak knee lawsuits assert that Exactech was aware that the implants were failing at a higher-than-expected rate by 2012, noting that:

  • The FDA has received multiple reports of Optetrak knee failures involving “loose tibial component”, “aseptic loosening”, “polyethylene wear”, “pain and visible loosening”, and “pain, limited mobility, knee swelling and sensitivity” due to a “loose” joint.
  • A study involving 110 Optetrak Knee Replacements published by Orthopaedics & Traumatology: Surgery & Research in 2012 found that “the small size of the tibial keel does not seem to resist the stresses applied by the ultracongruent shape of the posterior stabilization of this implant and the increase in intercondyloid eminence height.”
  • The Australian Joint Replacement Registry reported in 2016 that the Optetrak Knee had an extremely high failure rate as early as 3 years after implantation. The 5-year failure rate was 6.6%, while the rate at 7 years was 7.9%.

Finally, the complaints assert that Exactech ultimately conducted a “silent recall” to replace the finned tibial tray with a “fitted” component that would result in better patient outcomes.

“The fact that Exactech made this “silent recall” device replacement indicates the company knew – or should have known – about the failures of their Optetrak knee replacement product, and that it was not safe for patients,” the lawsuits charge.

Optetrak Knee Replacement Failures & Revision Surgery

Symptoms of Optetrak Knee Replacement failure include:

  • Knee pain, ranging from mild to severe
  • Reduced mobility
  • Instability due to loosening of the implant
  • Loss of range of motion
  • Swelling in the knee
  • Inflammation and reddened skin
  • Difficulty walking or standing
  • Balance problems

Some individuals who have experienced complications following implantation of an Optetrak Knee have been forced to undergo revision surgery to remove and replace their implants.

Knee revision surgery takes longer, is far more complicated, and is more likely to result in complications compared to a standard knee replacement procedure. For one thing, the surgeon must remove the original prothesis, which will have likely grown into the bone at that point. Thus, a bone graft may be needed to support the new implant.

Learn If You’re Eligible to File an Optetrak Knee Replacement Lawsuit

Individuals who experienced the premature failure of an Optetrak Knee implanted in 2011 or later may be entitled  for financial compensation for all of their injury-related damages, including:

  • Medical bills
  • Lost wages
  • Permanent disability
  • Pain and Suffering
  • More

To learn if you qualify to file an Optetrak Knee Replacement lawsuit, please call (888) 994-5118

  1. Orthopaedics & Traumatology: Surgery & Research (2012) “Poor results of the Optetrak™ cemented posterior stabilized knee prosthesis after a mean 25-month follow-up: Analysis of 110 prostheses.” https://www.sciencedirect.com/science/article/pii/S1877056812000758
  2. AOA National Joint Replacement Registry (2016) “Hip, Knee & Shoulder Arthroplasty Annual Report” https://aoanjrr.sahmri.com/documents/10180/275066/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty
Last Modified: May 9, 2018

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