Exactech Replacement Recalls

Recalled Exactech devices include almost all polyethylene liners in its knee, hip and ankle implants because of defective packaging that can cause polyethylene liners to degrade prematurely. Initially, the company recalled its GXL Connexion liners in June 2021 and later expanded the recall to all hip liners. In August 2021, the company issued a recall for its knee and ankle implants.

The FDA classifies these recalls as Class II. This means these recalled devices may cause serious injury or temporary illness.

Exactech manufactured the affected devices between 2004 and August 2021. This recall includes about 533,160 devices in total. In April 2022, Exactech said about 147,732 knee and ankle devices were implanted in the U.S. since 2004.

“The Exactech recall goes all the way back to devices from 2004, and it’s basically company-wide and affects nearly every Exactech model. It’s different from other medical device recalls such as the DePuy ASR or Stryker Rejuvenate recalls because those were very specific models. In this case, it’s almost all of the Exactech replacements,” according to mass torts and product liability attorney Daniel Nigh.

The recall has led hundreds of people to file Exactech lawsuits. As of April 2024, there were 1,401 Exactech recall lawsuits pending in multidistrict litigation before the U.S. District Court for the Eastern District of New York.

In January 2024, the FDA warned about the Exactech Equinoxe Shoulder System’s safety because of its defective packaging, which resembled the packaging of other recalled hip, knee and ankle devices. But as of now, Exactech has declined to issue a recall. The FDA warned that these devices may have to be replaced to correct problems.

Previously Reported Exactech Replacement Problems

Before the current recalls, Exactech faced problems with its joint replacements. Since the original Optetrak Knee System was introduced in 1992, it has had higher revision rates compared to other knee replacements. Data from Australia, New Zealand and the United Kingdom reported revision surgery rates increased as high as seven-fold compared to other devices.

It has also faced a whistleblower lawsuit that said the company knowingly gave faulty knee replacement devices to Medicare, Medicaid and Department of Veterans Affairs beneficiaries.

According to Exactech, most of their knee, hip and ankle replacements manufactured since 2004 came with polyethylene plastic inserts packaged in “out-of-specification” bags that could allow oxygen to reach the inserts. This increased oxygen exposure could cause the liners to severely degrade the liners.

While Exactech has officially said the recall was related to faulty vacuum bag packaging that could cause early damage to implant liners, Daniel Nigh believes there’s more to the recall.

The U.S. Food and Drug Administration classified the recall as a Class II. This means the recalled liners could lead to temporary or reversible health consequences.

Potential injuries associated with recalled knee and ankle liners include early failure, bone loss and component fracture that could lead to revision surgery. Revision surgery is a more complicated surgery than a primary joint replacement and often requires longer surgery times and special implants.

Problems with Recalled Exactech Knee Implants

According to Exactech, recalled knee and ankle devices may be associated with problems from increased premature wear to increased revision rates.

The company said these problems were potentially related to the defective packaging that caused oxidation and degradation of the plastic inserts in the knee implants.

Exactech Hip Implant Early Failure

Exactech has informed surgeons that under certain conditions patients with hip replacements that use the GXL liner may be at risk for higher wear rates.

While many implants last for 10 to 15 years, studies showed the average time to revision for Exactech hip implants with defective liners was approximately five years. Most people who suffered premature wear complained of hip or groin pain, but the company also observed that premature wear in asymptomatic patients.

Exactech notified surgeons about the recall and your surgeon may contact you to schedule a follow-up appointment if your implant is on the recall list. But if you are concerned and don’t hear from your doctor, you can contact their office to see if your implant has been recalled. Exactech may also have sent you a recall letter.

“My wife had a right knee replacement utilizing Exactech prosthetics approximately nine years ago. All went well until the last two years when she began having trouble. About the time that the knee pain was getting worse, we were notified by Exactech about the recall due to the improperly stored pad prior to the original surgery,” RG, who used initials to identify himself for privacy reasons, told Drugwatch.

In addition, you can look up your knee or ankle implant serial number on Exactech’s website. The serial number should be in your medical records. You can also contact Exactech directly at 1-888-912-0403.

Possible Implant Failure Symptoms

“As a pain management specialist, I’ve worked with countless patients who have suffered from chronic pain due to hip or knee implant issues. One of the primary symptoms that we often see in these patients is pain or discomfort that persists beyond the expected recovery period,” Dr. Thomas Pontinen, double board-certified pain management expert and surgeon, told Drugwatch.

The number one symptom of a faulty implant is pain, but make sure you contact your doctor to see if you need to monitor your implant for potential future issues even if you don’t have symptoms now.

Usually, symptoms associated with polyethylene wear relate to bone loss or the release of excessive particle debris from the degraded liner. However, some people may suffer bone loss, also called osteolysis, without symptoms.

If you have any of these symptoms, contact your doctor right away. They can discuss treatment options, including potential revision surgery to replace the defective insert or the entire device or a plan for pain management.

If the Exactech knee and ankle recall impacts you, schedule an appointment with your surgeon if they have not already contacted you. You can discuss the risks and benefits of potential revision surgery with your doctor.

But if you aren’t having problems, your doctor may just continue to monitor you because Exactech doesn’t recommend surgery if you are asymptomatic. Early device wear and bone damage may occur even without symptoms, so monitoring your device is crucial.

Some patients may choose to contact Exactech to be reimbursed for out-of-pocket costs, such as medical bills from doctor visits or potential revision surgery. Exactech is working with a third-party company called Broadspire to handle claims.

An Exactech claim may not reimburse you for other physical or emotional damages. Lawyers are currently investigating Exactech claims, and patients may choose to file Exactech replacement lawsuits for compensation for medical bills, lost wages, pain and suffering and other damages.

Even if you don’t have symptoms, consider speaking with an attorney to preserve your right to file a lawsuit, because some states have deadlines of as little as one year to file a claim.