Exactech OPTETRAK Knee, Ankle, and Hip Recall Lawsuits

Exactech Initiates Massive Knee, Ankle, and Hip Replacement Device Recall

On February 7, 2022, Exactech, a medical device company headquartered in Florida, expanded a prior recall of knee and ankle replacement devices. This updated recall now affects roughly 150,000 devices distributed in the U.S. from 2004 through 2022. In addition, Exactech also recently recalled the Connexion GXL Acetabular Liner, affecting close to 90,000 hip devices. Due to polyethylene (plastic) wear, these massive recalls stem from significantly higher revision rates and early failure due to polyethylene (plastic) wear. The Exactech implants showed a three to seven-fold increased failure rate versus other arthroplasty devices.

Issues with Exactech Recalled Devices:

  1. Statistically significant higher and earlier than expected revision rates;
  2. Increased risk of polyethylene (plastic) wear;
  3. Potential development of osteolysis (bone loss);

Exactech Devices Affected by Recall:

  1. OPTETRAK® Posterior Stabilized Knee - Available since 1994
  2. OPTETRAK Logic® Primary Knee System - Available since 2009
  3. TRULIANT® Tibial Inserts – Available since 2017
  4. VANTAGE® Total Ankle System – Available since 2016
  5. Connexion GXL Acetabular Liner - Available since 2005

Please contact your physician(s) if you are not sure whether your replacement component is affected by the recall, and request that they check the serial number of your component against the Exactech list of affected devices.

Problems with the Exactech Device

The four parts of a standard total knee replacement include:

  1. The femoral component – a metal piece that attaches to the thigh bone
  2. The tibial tray – a metal piece that fits into the shin bone
  3. The patellar component – a piece of plastic that fits onto the kneecap
  4. The tibial polyethylene insert – a plastic insert that fits between the femoral component and the tibial component and acts as the new cushion for the replaced knee joint.

A standard total knee replacement consists of three parts:

  1. The tibial component – a metal piece that attaches to the shin bone
  2. The talar component – a metal piece that girls into the foot bone
  3. The polyethylene insert – a plastic insert that fits between the tibial component and the talar component and acts as the cushion or cartilage for the replaced ankle joint.

Exactech found that one of the packaging layers for the polyethylene insert used in both the total knee replacement and the total ankle replacement did not conform to specifications. According to Exactech's letter to implanting surgeons, the company packaged most polyethylene inserts manufactured since 2004 in non-conforming vacuum bags. The bags failed to include a secondary barrier level which should have increased the oxygen resistance of the vacuum bag. The layer may allow oxygen from the air to diffuse into the plastic insert before being implanted in the knee or ankle. When a large amount of oxygen spreads into the plastic insert during storage, it can lead to oxidation before the insert is implanted. Oxidation can wear out prematurely and cause damage to the plastic after it is implanted in the patient's body, causing injury to the patient. In addition, without the plastic insert, there is no cushioning to absorb the impact of movement, causing pain and injury to the patient.

What are the Symptoms of an Exactech Knee, Hip, or Ankle Failure?

Complications: The current complications associated with polyethylene wear include:

Don't wait to hear from your surgeon if you are experiencing any of these symptoms:

  • Loosening/Instability
  • New or worsening pain
  • Inability to bear weight
  • Grinding, clicking, or other noise
  • Swelling
  • Osteolysis (Bone Loss)
  • Revision surgery

If you received a total knee replacement or a total ankle replacement after 2010 with components or inserts manufactured by Exactech, you should contact your physician to determine if your device is affected by the recall.

If your device is included in the recall, it's crucial that you contact a personal injury law firm to discuss your legal options.

Your surgeon will examine you and conduct x-rays to assess the condition of your plastic insert. Depending on the results, your surgeon will decide if you need revision surgery or any other necessary course of action.

What is Exactech Offering?

Although Exactech has committed to assisting patients with some out-of-pocket costs related to clinical follow-up and revision surgery, you may be entitled to more compensation than Exactech is offering. You may be able to recover for damages including:

  • Lost wages if you missed or will miss work because of your ankle or knee replacement
  • Pain and suffering
  • Related medical expenses

How much compensation you can recover will depend on the specific facts of your case.

We stand ready to hold Exactech responsible for their product failure. Reach out to our personal injury and product liability attorneys for a free, confidential consultation. You can call us 24/7 at 412-618-2734.

How Much Does It Cost to Hire a Knee, Ankle, and Hip Replacement Lawyer?

Hiring an attorney from Edgar Snyder & Associates will cost you nothing unless and until we win your claim. Even your initial consultation is free.

At Edgar Snyder & Associates, we're in your corner, and we have over 35 years of experience to help you. We start building your case right away, and we won't quit until we get the money you deserve. Remember, there is never a fee unless we get money for you.

Contact a Knee, Hip, and Ankle Replacement Attorney Today

The right personal injury and product liability attorney can make a world of difference in your case. Our firm has decades of experience helping families who have suffered injuries due to no fault of their own. We put our resources to work for you right away and stay by your side from start to finish, helping you decide what your next steps should be.

Knee, ankle, and hip replacement lawsuits are complicated. From knee, ankle, and hip replacement manufacturers to medical records to witnesses, our law firm handles all of it so you can focus on your family.

You can contact us by phone at 412-618-2696, chat, or the form at the top of the page. All consultations are free and come with no obligation to use our services.

And "There's never a fee unless we get money for you." So that means that unless and until your case is successful, you don't owe us a dime.

If your Exactech knee replacement implant failed and you had to undergo corrective surgery, our lawyers can help you. Call our law firm today at 412-618-2696 or get a free online consultation today to see if you have a case.

Note: Litigation may involve co-counsel.

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