Exactech Issues Urgent Ankle Replacement Recall for Polyethylene Inserts
More than 1-thousand five hundred Exactech ankles implanted into patients’ bodies could be dangerously defective.
In August 2021 Exactech issued a Class II FDA recall for the plastic tibial insert on their Vantage ankle replacements. At that time Exactech notified surgeons to stop using the device and pull the plastic inserts made over the past 8 years from the shelves.
In April 2022 Exactech issued a recall update to remove and stop using ALL Vantage ankle replacements regardless of when they were made. The company confirmed that most of the plastic inserts made since 2004 could be defective.
What Is Wrong With Recalled Exactech Vantage Ankle Replacements?
The plastic part of the ankle replacement is called the tibial liner. Exactech admits that the vacuum bags that packaged these plastic liners were defective as far back as 2004. After extensive testing, Exactech confirmed that approximately 80% of their inserts manufactured since 2004 were packaged in these defective vacuum bags.
So what’s wrong with the bags? They should have 2 layers to keep oxygen away from the plastic liners. Instead, the vacuum bags did NOT contain a secondary barrier layer needed to keep oxygen out. When oxygen seeps through the defective package it can corrode or oxidize the plastic in the ankle replacements.
This unintended exposure to oxygen can weaken the plastic. When that happens, the plastic becomes brittle and is more likely to wear out sooner than expected. Once the plastic insert is inside your body, the constant use of the artificial joint can degrade the tibial insert and release particles that can cause pain, tissue damage, and other symptoms. Patients expecting their Exactech ankle to last 20-years are finding their implants need revising, meaning to have them removed and replaced, after only a few years.
Mctlaw Attorneys Wins Fight to Consolidate Exactech Cases, Trial Date Set
Justice is moving swiftly for people hurt by defective Exactech hips, Exactech knees, and Exactech ankles. Mctlaw attorney, Ilyas Sayeg won arguments to move all FL Exactech lawsuits into a consolidated master case in Alachua County, FL.
Exactech is a Gainesville-based company, and this means that cases against them, no matter where a person lives, can be filed in Alachua County, FL. Grouping the cases all together helps them get heard as quickly as possible. In addition to setting a quick trial date, Hon. Donna Keim holds monthly case management meetings to help move the case along quickly.
Mctlaw is leading the way in this litigation and is committed to doing our part to get justice for those impacted by faulty Exactech medical hips, knees, and ankles. No matter what state you live in, we can help you file your claim in Florida and get representation from the law firm that made the consolidation of the cases possible.
What Should I Do if I Have an Exactech Ankle Implant?
Exachtech recommends patients who were implanted with a Polyethylene Vantage fixed-bearing liner component in the past six years, and who haven’t seen their surgeon in at least a year, should see their doctor now.
Even if you’re not experiencing symptoms, it is essential to have routine exams to monitor your situation.
Also, contact mctlaw immediately to help protect your rights and provide you with a free case review. We can help request the right medical records on your behalf, at no cost to you.
Every patient’s situation is unique and has its own complexities; our attorneys handle each client’s case with the care and respect they deserve. There is limited time to file a lawsuit for a defective ankle replacement injury. Don’t wait, or you may run out of time to file a claim.
Warning About Giving Your Information to Exactech
Exactech encourages patients to file for reimbursement for out-of-pocket medical expenses through Exactech-Broadspire. They tell you that Exactech will cover your medical costs. We believe this is a mistake. You may be signing away your rights and agreeing to a settlement that may not be in your best interests.
Exactech also provides a helpline and a way to look up your implant by the serial number. Be careful what information you give them because that can also impact your ability to file a claim against Exactech in the future.
We highly suggest you contact the attorneys at mctlaw before contacting Exactech about your ankle implant. Let our attorneys request and review your medical records to see if you have a claim.
What To Ask a Lawyer About Filing a Recalled Exactech Ankle Claim
It’s essential to hire an attorney based on experience. The law firm you hire should have the financial resources to litigate against giant corporations that will try to derail your lawsuit. mctlaw has the resources, expertise, technology, and knowledge to help you get the best possible outcome.
Our firm currently represents more than 500 people with defective hip replacements. Look at our client map to see how many cases in each state we are representing.
Our firm does not sue orthopedic surgeons. The problem is with the medical device and the manufacturers, sellers, and distributors who misled surgeons to believe the product was safe. Often your surgeon can help your case.
- Mctlaw has focused its practice on defective joint replacement cases for over a decade.
- Our attorneys are leading the litigation against artificial joint makers across the country.
- Our firm does not refer out Exactech cases. If we take on your case, we represent you.
- Mctlaw represents you at no cost unless we recover money from a verdict or a settlement. If you don’t get compensation, you owe us nothing.
Watch for Possible Symptoms of a Defective Exactech Ankle Replacement
Symptoms of polyethylene wear are usually related to bone loss or excessive particle debris released from the degraded liner.
But some people may suffer bone loss, also called osteolysis, without any symptoms at all.
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.
Symptoms to watch for include:
- Clicking on your ankle
- Inability to bear weight
- Noises such as grinding coming from the implant
- Pain while walking
- Swelling in the joint
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.
Most importantly, call the team at mctlaw to review your case. The lawyers at mctlaw filed some of the first cases in the country against Exactech and is in the beginning stages of investigating these claims.
Exactech Sends Warning Letter to Surgeons
Exactech sent letters to surgeons asking them to urgently notify their patients about the recall of the plastic ankle inserts. In the letter, Exactech asks surgeons to remove all plastic ankle inserts from their office inventory and to send them back to the company.
Not everyone with a defective Exactech ankle will get a letter
Exactech leaves it up to each individual surgeon to notify their patients. Doctors who have retired or practices that closed or changed physicians may not know to contact you. If you received an ankle insert and did NOT receive a recall letter, you may still have a recalled Exactech ankle. Contact us to find out.
Related Exactech Recalls
There are currently several Exactech medical implant device recalls. These recalls include:
If you have received one of these joint replacements, contact mctlaw for a free case review.
Content Reviewed by Ilyas Sayeg – Medical Product Liability Lawyer
Ilyas Sayeg is a partner at mctlaw working in the Firm’s product liability and complex consumer protection practices representing clients with failing metal on metal hip replacements and recalled Exactech hip and knee implants. Mr. Sayeg represents “Davids” nationwide who are injured by defective medical products and deceptive business practices of the corporate “Goliaths” who put profit before safety. A passionate advocate, he takes pride in standing toe-to-toe against some of the largest companies in the world to help his clients seek justice. Mr. Sayeg is a member of the American Association for Justice.
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