What to Know About the Exactech® Knee, Ankle and Hip Replacement Device Recall

Knee Issues

In August 2021, Exactech® — a Florida-based medical-device manufacturer — recalled certain models of ankle, hip and knee replacement devices due to a range of potentially dangerous health issues relating to the devices failing or breaking down prematurely.

In short, the U.S. Food and Drug Administration (FDA) identified several models of Exactech ankle, hip and knee replacements made with polyethylene inserts that were packaged in a way that exposed the inserts to too much oxygen. Due to the abundance of oxygen, the inserts broke down or failed prematurely while inside patients’ bodies.

Problems like these can lead to serious health complications, including the need for costly revision surgery to repair, remove or replace the defective device.

More than 7 million Americans are living with ankle, hip and knee replacements, according to the American Joint Replacement Registry (AJRR). Given how common ankle, hip and knee procedures are, potentially thousands of Americans have suffered health complications as a result of a defective Exactech device.

Exactech did not directly warn patients who have had one of their defective devices implanted. As a result, many patients are only now learning about potential implant defects after experiencing adverse symptoms and health complications.

How Defective Exactech Implant Devices Have Harmed Patients

When an Exactech implant breaks down, it can cause the device to loosen or fail, leading to potentially severe physical symptoms and mental anguish.

Physical health issues from defective Exactech ankle, hip and knee replacement products may include:

  • Bone fracturing
  • Clicking, grinding, popping or other noises
  • Dislocations
  • Inability to bear weight
  • Instability in the knee, ankle or hip
  • New or worsening pain
  • Osteolysis (bone degeneration)
  • Premature wear or device failure
  • Swelling

Injuries and/or conditions like those above can be painful, debilitating and life-altering. As a result, individuals experiencing the symptoms of a defective implant device may find managing everyday tasks difficult — or even impossible. In many cases, in order to address painful symptoms, revision surgery is required.

Unfortunately, revision surgery is an invasive and complex procedure that:

  • Can cost thousands of dollars
  • Comes with risks, including but not limited to infection, damage to nerves or blood vessels, aggravation of prior medical conditions and death
  • Requires prolonged operating times and advanced surgical techniques to be successful
  • Requires months of recovery, including costly physical therapy
  • Leads to persistent pain in up to 20% of patients, in some cases lasting several years

A recalled Exactech joint-replacement device can become a costly and life-altering burden to patients who have had such a device implanted in their bodies. The FDA’s recall includes all knee and ankle inserts packaged in defective bags “regardless of [its] label or shelf life.”

To see a full list of Exactech product models included in the recall, visit our Exactech recall page.

What to Do If You’ve Experienced Symptoms

If you or a loved one has an Exactech ankle, hip or knee replacement device and is experiencing adverse side effects, it’s important to speak with your doctor right away. Your doctor will be able to diagnose any complications and advise you on whether replacement surgery may be required.

You may be eligible to file an Exactech lawsuit if you:

  • Have a recalled Exactech ankle, knee or hip replacement device
  • Suffered pain or injuries relating to the Exactech implant
  • Had, scheduled, or were told you needed revision surgery

The defective device attorneys at Simmons Hanly Conroy have a great track record in recovering compensation for individuals injured by implant devices. Recently, firm attorneys represented six individuals injured by DePuy Pinnacle metal-on-metal hip implant devices, securing a $1 billion verdict on their behalf.

For years, our firm has successfully held companies accountable for the injuries they’ve caused our clients, securing more than $9 billion nationwide. Contact us today to see if we may be able to help in your situation.

Simmons Support Team
Simmons Hanly ConroyWritten by:

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The Simmons Hanly Conroy Editorial Team consists of journalists, writers and editors who strive to deliver accurate and useful information to families needing legal help. Our team works alongside the firm's attorneys and shareholders, as well as with medical professionals and other specialists, to keep all information relevant and helpful.

View 5 Sources
  1. American Joint Replacement Registry. “American Joint Replacement Registry Releases 2021 Annual Report, Showing Increase in Number of Hip and Knee Procedures Despite Pause Due to COVID-19.” Retrieved from https://www.aaos.org/aaos-home/newsroom/press-releases/american-joint-replacement-registry-releases-2021-annual-report/. Accessed May 4, 2022.
  2. American Association of Hip and Knee Surgeons. “Total Hip Replacement.” Retrieved from https://hipknee.aahks.org/total-hip-replacement/. Accessed May 4, 2022.
  3. Hospital for Special Surgery. “Revision Total Knee Replacement: Frequently Asked Questions (FAQs).” Retrieved from https://www.hss.edu/conditions_revision-total-knee-replacement-faqs.asp. Accessed May 4, 2022.
  4. University of Utah. “Signs of Hip or Knee Replacement Failure.” Retrieved from https://healthcare.utah.edu/orthopaedics/specialties/joint-replacement/hip-knee-revision/replacement-failure-symptoms.php. Accessed May 4, 2022.
  5. Simmons Hanly Conroy. "Exactech Ankle, Hip & Knee Replacement Lawsuit." Retrieved from https://www.simmonsfirm.com/drugs-devices/exactech-implants/. Accessed May 4, 2022.

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