Exactech Replacement Recalls | Hip, knee and ankle units (2023)

Exactechbegan removing the polyethylene liners from some of its knee and ankle implants in August 2021.

In February 2022, the company expanded the recall to include "all polyethylene knee and ankle arthroplasty inserts packaged in non-compliant packaging, regardless of label or expiration date," according to Exactech's recall notice. In October 2022, the Multi-District Litigation Judicial Panel on Friday consolidated at least 75 lawsuits against Exactech. The company has withdrawn approximately 200,000 knee, hip and ankle replacements since August 2021.

In June 2021, Exactech sent a letter to physicians that it was phasing out polyethylene.Exactech GXL connection linersused in their Novation, Acumatch and MCS systemship replacement products. This is not a recall, and the company will be transitioning to its new XLE polyethylene liner that is infused with vitamin E.

Recall of knee and ankle replacements

Exactech has recalled all Optetrak, Truliant and Vantage knee and ankle replacement casings manufactured from 2004 to the present. The company advised surgeons not to implant non-compliant products and to return compatible and non-compliant devices to Exactech.

Exactech knee and ankle replacements include:

If you have an Exactech implant and are not sure if you are being recalled, you can look up your device's serial number atSite Exactech.

GXL hip liners pose a risk of premature wear

As long as there is no GXL connectionhip replacement recallExactech advised surgeons that under certain conditions, hip replacement patients using the GXL liner may be at risk for higher wear rates. The company noted that a small percentage of patients (0.118%) who had their implants in for 3 to 6 years after their initial surgery may experience premature wear of the coatings.

Exactech has listed factors that may contribute to early wear of the GXL liner, including larger femoral heads, higher levels of patient activity, and devices implanted using a direct anterior implant.hip surgerygetting closer.

Exactech Connexion GXL coatings include:

Exactech claims that Connexion GXL coatings are safe and perform as expected, but will be phased out of the US market. Some patients presentedhip replacement lawsuitsagainst Exactech regarding issues with GXL coatings.

Previously reported Exactech replacement issues

Prior to the current recalls, Exactech had been experiencing issues with gasket 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 that revision surgery rates increased by up to seven times compared to other devices.

He also faced a lawsuit from whistleblowers who say the company knowingly provided faulty knee replacement devices to Medicare, Medicaid and Department of Veterans Affairs beneficiaries.

According to Exactech, most knee and ankle replacements manufactured since 2004 came with polyethylene plastic inserts packaged in "out of specification" pouches that allowed oxygen to reach the inserts. This increased exposure to oxygen can cause severe degradation of coatings.

The US Food and Drug Administration has classified the recall as Class II. This means that collected coatings can have temporary or reversible health consequences. In a Class II recall, the chance of serious health problems is remote. Potential injuries associated with knee and ankle relining include early failure, bone loss, and fractured components that may lead to revision surgery.

Revision surgery is more complicated surgery than a primary joint replacement and usually requires longer operating times and special implants. Medical device registries in Australia, UK and New Zealand found higher revision rates for Optetrak knee systems using the polyethylene liner.

Your surgeon may contact you to schedule a follow-up appointment if your implant is on the recall list. But if you're concerned and haven't heard from your doctor, contact the doctor's office to verify that the implant has been removed.

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

Exactech does not recommend revision surgery for patients whose knee or ankle implants are working well and have no symptoms.

Watch out for possible symptoms

Symptoms associated with polyethylene wear are usually related to bone loss or excessive release of particles from the degraded coating. But some people can experience bone loss, also called osteolysis, without symptoms.

Be sure to contact your doctor to find out if you need to monitor your implant for possible future problems, even if you don't have symptoms now.

Symptoms to look out for include:

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If you are affected by the Exactech Knee and Ankle recall, make an appointment with your surgeon if you have not already been contacted. If you have a hip implant with a GXL coating, you can also contact your surgeon, especially if you have symptoms.

Exactech recommends that clinicians closely monitor knee and ankle patients with inserts removed for possible osteolysis and overuse. They will use X-rays and other diagnostics to determine excessive wear or bone and tissue damage.

You can discuss the risks and benefits of potential revision surgery with your doctor. But if you don't have any problems, your doctor may continue to monitor you because further surgery is not recommended if you are asymptomatic.

Some patients may choose to contact Exactech for reimbursement of out-of-pocket expenses such as medical bills for doctor visits or possible surgery. Exactech's claims are being investigated by attorneys and patients can choose to file them.Exactech Replacement Processesfor compensation for medical bills, lost wages, pain and suffering, and other damages.

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