Exactech, a noted manufacturer of joint replacement devices, is currently involved in a wide-ranging recall relating to a large number of its implants that were used in knee, hip, or ankle surgery and later found to be defective. Exactech’s recall includes all of its knee and ankle polyethylene inserts that were packaged in defective vacuum bags. Due to inadequate design, these bags left the devices inside vulnerable to oxidation. Many individuals who have received these devices require revision surgery.
The recall has been given “Class II” designation by the U.S. Food and Drug Administration (FDA). This designation is used for medical products that have been determined to pose a moderate level of health risk to individuals using or being exposed to the product. A Class II recall indicates that the use of the product may cause temporary or medically reversible adverse health effects.
If you have received an Exactech knee or ankle replacement implant, you should contact your medical provider to ascertain whether your implant is among those that are covered by the recall. People who have been harmed by an Exactech implant may qualify for financial compensation. The nationally based legal team at Saunders & Walker P.A. is here to help you sort through your options.
What Products Are Included in the Exactech Recall?
To date, over 90,000 individuals have been implanted with potentially defective Exactech components. Products affected by the Exactech recall include the following:
- Optetrak® Tibial Inserts
- Optetrak Logic® Tibial Inserts
- Optetrak® All-polyethylene Tibial Components
- Acumatch GXL
- Novation GXL
- MCS GXL
- Truliant® Tibial Inserts
- Vantage® Fixed-Bearing Liner Component
- Acumatch Conventional UHMWPE
- MCS Conventional UHMWPE
- Novation Conventional UHMWPE
- Exactech All Polyethylene Cemented Cup
If you are not certain if you have received an implant covered by the recall, contact your medical provider. They should be able to look up the serial number associated with your device.
Why Exactech Devices Fail
Exactech’s knee and ankle implants manufactured between 2004 and 2021 included GXL polyethylene liners. Polyethylene is a type of plastic commonly used in joint replacement components due to its durability and ability to mimic natural cartilage. However, it is susceptible to oxidative degradation, which can occur when the material comes into contact with oxygen in the air.
Inadequate packaging or storage of the polyethylene insert before surgery can accelerate the oxidation process and worsen the damage. Factors that contribute to inadequate packaging or storage include exposure to air, moisture, temperature fluctuations, and light. If the polyethylene insert is exposed to these adverse conditions, the oxidation process can occur more rapidly, leading to a compromised insert even before it’s implanted into the patient.
This is what happened with these Exactech joint replacement devices. Due to a defect in the packaging—specifically the unintended absence of an oxygen barrier—the devices began to degrade prior to being implanted.
During knee, hip, or ankle total replacement surgery, the damaged or arthritic portions of the natural joint are removed, and the artificial components are securely attached to the bones using specialized techniques. The components work together to restore proper joint function, alleviate pain, and enhance mobility for individuals with severe joint degeneration or injury. In the case of Exactech implants, though, the faulty packaging led to patients receiving defective components that could not function correctly.
Updates to the Case
In June 2021, Exactech sent a letter to doctors informing them about the company’s decision to discontinue the polyethylene Exactech GXL Connexion liners used in its Acumatch, Novation, and MCS systems hip replacement devices and was switching to a XLE polyethylene liner. In August of the same year, Exactech began the recall of certain of its knee and ankle polyethylene liners that had been stored in defective bags.
Since then, the recall has gradually expanded and evolved, as follows:
February 2022: Exactec expanded a voluntary recall of knee replacement and total ankle replacement devices that had used the defective packaging.
April 2022: Exactech sent another letter, marked “URGENT,” to knee and ankle surgeons announcing that its recall has been expanded to include all of its knee and ankle arthroplasty polyethylene inserts. The letter also noted that around 80% of Exactech polyethylene inserts manufactured since 2004 had been stored in defective packaging.
October 2022: The Judicial Panel on Multidistrict Litigation consolidated more than 75 lawsuits against Exactech.
At present, the Exactech lawsuit continues to make its way through the courts, with new plaintiffs joining on a rolling basis.
Symptoms of Exactech Failure
Persons who have received an Exactech knee, hip, or ankle device may experience one or more of the following symptoms:
- Pain while walking
- Inability to bear weight on the affected area
- Grinding or clicking sounds in the affected area
- Recurring or worsening swelling in the ankle
- Instability on the affected knee or ankle
Contact your medical provider immediately if you are experiencing any of these symptoms.
What Can You Do If You Are Experiencing Discomfort Due to an Exactech Implant?
You need to be examined by a medical professional to verify whether your physical impairment is the result of a defective implanted device. Your doctor should conduct a few diagnostic tests to see the extent of the problem; these may include X-rays and MRIs. In many cases, your doctor will recommend revision surgery to correct the issue.
What Is Revision Surgery?
Revision surgery, also known as revision joint replacement or revision arthroplasty, refers to a surgical procedure that involves replacing or repairing a previously implanted medical device, such as a joint replacement, that has become damaged, worn out, or otherwise compromised. Revision surgery is typically performed when the original implant has failed or is no longer functioning as intended.
In the context of joint replacements, such as hip or knee replacements, revision surgery becomes necessary for a variety of reasons, including:
Implant Wear and Tear – Over time, the materials used in joint replacement implants can wear down due to normal use and movement. This wear can lead to the release of debris into the surrounding tissues, causing pain, inflammation, and reduced functionality.
Loosening – The components of a joint replacement may loosen from the bone over time. This can result in pain, instability, and reduced joint function. Loosening often requires revision surgery to replace the loosened components and restore proper fixation.
Infection – In some cases, joint replacements can become infected, either shortly after the initial surgery or years later. Infections can be difficult to treat and may necessitate the removal and replacement of the infected implant.
Fracture or Breakage – The components of a joint replacement can fracture or break, leading to instability, pain, and limited mobility. Revision surgery is required to replace the fractured components.
Revision surgery is typically more complex and challenging than the initial joint replacement procedure. It often involves addressing the issues that caused the failure or complications of the original implant, which may require additional surgical techniques, specialized implants, and careful planning to achieve the best possible outcome.
At the present time, Exactech does not advise revision surgery for patients who are not experiencing symptoms associated with a defective implant, even if they have an implant that is covered under the recall.
Contact a Product Liability Attorney Today
If you or someone close to you has been harmed by a defective Exactech implant, please contact us immediately. Although Exactech has set up a “helpline” for patients who want to make a claim, it is important to realize that any compensation you may receive through this channel may fall considerably short of what you would obtain with the assistance of an experienced product liability attorney. That’s what you get when you work with the team at Saunders & Walker P.A. We handle Exactech recall lawsuit cases from all over the U.S.
For a free case evaluation, call us at (727) 579-4500.