Exactech Hip Replacement

The FDA issued a reminder that Exactech hip recall devices can lead to complications and revision surgery. The warning identifies plastic liners used in the company’s Acumatch, MCS and Novation hip systems. There are currently 391 pending legal actions covering all recalled Exactech devices.

Last Modified: November 13, 2023
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How Do Exactech Hip Replacements Work?

During total hip arthroplasty (hip replacement), decayed bone and cartilage are replaced with a prosthetic joint consisting of a ball at the head of the femur and a cup at the hip. People have hip replacements to treat osteoarthritis and rheumatoid arthritis, loss of blood flow and injuries.

Exactech replacements use implants made from metal, ceramic and plastic components. In 2021, Exactech recalled some of its GXL polyethylene liners after reported patient complications. Exactech extended its hip replacement recall in 2022 to all polyethylene parts manufactured in faulty bags. In March 2023, the FDA released a reminder about Exactech recall components.

Key Facts
  • Osteoarthritis from cartilage degradation is the top reason people seek hip replacement therapy.
  • Roughly 450,000 total hip replacement surgeries are performed in the U.S. each year.
  • By 2040, an estimated 2 million hip replacement surgeries will be performed each year.
  • The need for revision surgery increases to nearly 15% when a hip replacement has been in place for around 20 years.
  • Faulty Exactech hip implants began breaking down in less than five years.

Exactech was phasing out its GXL liners before the first recall. In 2022, the company received a U.S. Food and Drug Administration breakthrough device designation for its Polymotion Hip Resurfacing System. The implant includes the XLE liner, made from high-grade polyethylene blended with antioxidant vitamin E, and a cobalt-chromium cup to counter oxidation. The first surgeries using the Polymotion system occurred in early 2023.

Exactech Hip Replacement Complications

Pain, discomfort and tenderness are common symptoms after hip replacement surgery. However, complications might arise if you have an Exactech hip system that has a faulty component. These complications include limited mobility, implant loosening, osteolysis (bone degeneration), inflammation, excessive pain and joint stiffness.

A 2020 study found accelerated wear of Exactech Connexion GXL liners in the company’s hip implants. This showed links to patient bone decay (osteolysis) and tissue inflammation (synovitis ). Within five years, patients had to undergo revision surgery to remove the implants.

Reported Complications
  • Accelerated device erosion
  • Bleeding
  • Blood clots
  • Bone degeneration (osteolysis)
  • Bone fracture
  • Device failure
  • Device fracture
  • Dislocation
  • Implant loosening
  • Infection
  • Leg length difference
  • Limited mobility
  • Nerve injury
  • Pain
  • Revision surgery
  • Stiffness

If you received an Exactech hip implant with a manufacture date between 2004 and August 2021, it is important to recognize symptoms and seek medical advice. You may require revision surgery.

Lawsuit Information
Some recalled Exactech hip replacements have caused complications in patients, leading to revision surgery. Learn more about the lawsuits associated with these recalls.
View Lawsuits

Exactech Hip Replacement Revision Surgery

A total hip replacement implant has an expected lifespan of up to roughly 20 years. Doctors may suggest revision surgery when the implant has eroded or is faulty, causing inflammation, joint loosening and bone degeneration. During revision surgery, surgeons either fully or partially replace the hip implant.

Revision surgery isn’t without risks. High rates of lingering pain, infection and blood clots have occurred. Still, medical professionals might recommend revision surgery in cases of extreme infection, pain, necrosis (bone and tissue death) and implant failure.

Faulty packaging of Exactech Connexion GXL liners, components the company issued between 2004 and August 2021, may have led to oxygen exposure. Oxidation can cause premature deterioration or total failure. Doctors often recommended revision surgeries for patients whose Exactech hip replacement recalled devices caused serious complications, including bone decay and tissue inflammation.

Was There an Exactech Hip Recall?

In March 2023 the FDA issued a reminder that devices from the Exactech hip replacement recall might cause complications or fail. The warning follows the 2021 and 2022 recalls of GXL plastic liners used in Exactech’s Acumatch, MCS and Novation hip systems.

In 2021, Exactech issued a letter to surgeons warning that some of the polyethylene Connexion GXL liners used in its hip systems were vulnerable to accelerated erosion. In August 2022, the Exactech replacement recall expanded to include all GXL liners packaged in bags missing an oxygen protective barrier.

Exactech Recalls and Warnings
  • October 2023: There are 842 pending cases related to Exactech hip recall components pending in MDL-3044.
  • March 2023: The FDA issues a reminder that Exactech hip implant components made between 2004 and August 2021 have links to accelerated degeneration and revision surgery.
  • September 2022: The FDA classifies the Exactech recall for its GXL liners as a Class II recall, with the potential for “medically reversible adverse health consequences.”
  • August 2022: Exactech expands its hip replacement device recall to include all polyethylene components packaged in defective bags. The company writes an urgent letter to health care professionals.
  • July 2022: Exactech encourages hip replacement patients to get a medical evaluation if their device contains a recalled polyethylene liner.
  • June 2021: Exactech recalls some of its GXL liners for Novation, Acumatch and MCS hip replacement devices related to premature wear. The company issues an urgent warning to surgeons and health care professionals.

If you’re experiencing symptoms that might be related to your Exactech recall replacement device, contact your healthcare provider. If you’re experiencing worsening pain linked to your Exactech hip replacement recalled component, you may require revision surgery. You might also be eligible to file an Exactech hip lawsuit.

Exactech Hip Replacement Lawsuits

Patients have filed Exactech hip lawsuits related to faulty polyethylene components in the hip replacement systems. As of October 2023 there were 842 cases pending in MDL-3044 concerning Exactech joint devices.
Recalled plastic components have links to an increased risk of implant damage or failure. Patients report excessive pain, swelling, limited mobility and device malfunction, among other symptoms. Doctors have reported osteolysis and synovitis in implant recipients leading to revision surgery.

Exactech hip lawsuits allege product liability and personal injury as a result of device failure. Legal estimates for Exactech settlements range between $100,000 and $300,000. There are ongoing Exactech replacement lawsuits involving Exactech ankle replacement devices and Exactech knee replacement devices.

What Should I Do if I Have an Exactech Hip Replacement?

If you have an Exactech hip replacement recall device, you may require revision surgery. Follow any postoperative instructions and pay attention to symptoms. Arrange a follow-up visit with your doctor or surgeon.

The FDA advises medical professionals to closely monitor Exactech hip recall patients. It recommends keeping Exactech implants in place if they are not causing pain or complications.

If you think there might be a problem with your Exactech hip device, the FDA encourages you to report it via its MedWatch Voluntary Reporting form. If you would like to find out whether you are eligible for an Exactech lawsuit, contact a legal professional experienced in joint implant claims.

Please seek the advice of a medical professional before making health care decisions.