Exactech recalled more than 1,500 Vantage® ankle replacements that can wear out or break within a few years, which would require corrective surgery.
Need a Texas Exactech Ankle Replacement Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured or needed surgery for an Exactech ankle replacement, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Exactech Warns Doctors About Ankle Replacement Problems
On February 7, 2022, Exactech issued an “Urgent Medical Device Correction” letter to surgeons, hospitals and healthcare professionals to warn about serious problems with knee and ankle replacements.
What is the Risk?
A plastic insert in the recalled Exactech ankle replacements can wear out prematurely, crack, or break. Patients are also at risk of bone loss. All of these problems can lead to corrective revision surgery.
Exactech Recalls 1,500 Vantage Ankle Replacements
Exactech announced a Class II recall for approximately 147,000 knee and ankle replacements that came with a defective plastic insert.
The recall covers about 1,561 units of the Exactech Vantage® Ankle Replacement Systems that have been sold in the U.S. since 2016.
What is the Problem?
The plastic insert — also known as the Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) — was designed to be implanted in between the metal parts of an ankle replacement to cushion the joint.
Unfortunately, the plastic inserts were packaged in a “non-conforming” or “out-of-specification” vacuum-sealed bag that did not actually prevent oxygen from coming in contact with the plastic material.
When the plastic insert was exposed to oxygen, it could degrade more quickly, and potentially lead to failure of the entire ankle replacement.
According to Exactech:
“Over time, oxidation can severely degrade the mechanical properties of [the implant], which, in conjunction with other surgical factors, can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”
Failing Ankle Symptoms to Watch Out For
Patients with a failing ankle replacement may experience symptoms such as:
- New or worsening pain
- Unable to put weight on the ankle
- Grinding sound or other noise
- Unstable ankle joint
Prognosis & Long-Term Outlook for Patients
Patients who have a non-painful, well-functioning ankle replacement do not need to have preemptive corrective surgery, according to Exactech. However, patients who are experiencing symptoms will need to have an X-ray to further investigate the problem. If a doctor suspects that the plastic insert is failing, corrective surgery to replace the insert (or potentially other parts of the implant) may be necessary.
Need an Exactech Ankle Replacement Lawyer in Texas?
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