Exactech Optetrak Knee Implant Drug Lawsuit SourceExactech Optetrak Knee Replacement

Commonly asked questions about Exactech Optetrak knee implant:

What Is the Exactech Optetrak Knee Implant?

The Optetrak knee implant is a device used in knee replacement surgeries that is manufactured by Exactech, Inc. According to reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database, there have been numerous reports of early failure of Exactech Optetrak devices.

The Optetrak knee implants released prior to 2011 were manufactured with a new design that differed from Exactech’s previous models. The Optetrak devices featured a “finned” tibial tray, which was found to be problematic.

The finned design did not promote adherence to the surgical cement used to attach it, which can prevent the device from being able to endure stress placed on the joint.

Two years later, Exactech changed their Optetrak knee devices to have a “fit” tibial tray in an effort to remedy the situation.

The Optetrak devices were brought to the market via the FDA’s 510(k) process of approval. This means that the device simply had to have a similar intended use and be at least as safe and effective as a device already on the market. If the device is determined to be substantially equivalent to an existing device, no further testing needs to be done.

This “fast-tracked” method clearly prevented a serious device defect from being detected, and hundred of patients suffered complications as a result.

What are Complications of the Exactech Optetrak Knee Implant?

According to the FDA, serious complications may be associated with any total knee joint replacement procedure. In the case of an Optetrak knee implant, if the device has not adhered to the surgical cement properly because of the “finned” design, you could experience these symptoms:

  • Loose tibial component
  • Pain
  • Limited mobility
  • Knee swelling and sensitivity
  • Visible loosening
  • Necessary revision surgery due to loosening

Was the Exactech Optetrak Recalled?

Although there was a Class 2 Device Recall of the Optetrak Tibial Tray in 2011, the stated reason was for mislabeling and not any defects of the device itself.

Instead of a defective device recall, Exactech systematically replaced customers’ old inventory of the device with the new version that was redesigned in 2013 with the “fit” tibial tray.

This “silent recall” indicates to many that Exactech did in fact know of the Optetrak’s faulty design, but continued to market the dangerous device to patients.

What are the Criteria for Filing an Exactech Knee Implant Lawsuit?

If you received an Exactech Optetrak knee implant and suffered serious complications, you could be entitled to compensation for your injuries. In order to file an Exactech knee replacement lawsuit, certain criteria must be met, including:

  • Received Exactech knee implant in 2011 or later
  • Had revision surgery to replace the implant
  • Had the original implant for eight years or less prior to revision surgery

Can I File A Defective Exactech Optetrak Knee Implant Lawsuit?

Our dangerous device attorneys can help if you or someone you care about was harmed by knee replacement surgery.

Lawsuits have been filed against Exactech by both patients and their families seeking compensation for injuries caused by the Optetrak devices. You may be entitled to a settlement.

We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you.

Our defective knee lawyers will help you file your lawsuit.

Our No-Fee Promise on Exactech Optetrak Cases

You can afford to have our great team of lawyers on your side. When you choose us, it literally costs nothing to get started. We promise you in writing:

  • No money to get started
  • We pay all case costs and expenses
  • No legal fees whatsoever unless you receive a settlement
  • Phone calls are always free

How Do I Start A Knee Replacement Claim?

Our knee replacement lawyers will help you file your lawsuit. To get started, you can:

  1. Submit the Free Case Review Box on this page, or
  2. Call (866) 280-3417 any time of day to tell us about your case.

We will listen to your story and answer your questions. If you have claim, we will start immediately.

WARNING: There are strict time deadlines for filing Exactech Optetrak knee replacement lawsuit claims.

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