New Health Warnings Issued For Patients with an Exactech Surgical Implant
Exactech has issued an urgent medical health care communication to physicians across the country, warning them of potential problems with the polyethylene plastic inserts used in tens of thousands of its knee, hip, and ankle replacement devices.
If you, or a loved one, have received a letter from your surgeon informing you of an Exactech knee, hip, or ankle replacement, you may have already experienced painful side-effects and could be entitled to significant compensation. However, Exactech has yet to establish any process for patients to recover their losses and move past their newfound injuries.
You do not have to wait to get the relief: please call Justinian & Associates at (512) 980-0000 today to schedule your free, no-obligation consultation.
Exactech’s Knee and Ankle Replacements Are at Risk of Critical Failure
While Exactech has previously recalled hundreds of its knee and ankle replacement devices, the company recently expanded its recall to include all such devices manufactured, packaged, and shipped between 2004 and 2022.
Exactech and scientists at the federal Food and Drug Administration are continuing to investigate the affected products. However, research suggests that many of Exactech’s polyethylene plastic inserts were packaged in “out-of-specification” bags.
Even though the out-of-specification bags were vacuum-packed, they did not have a standard, secondary barrier of ethylene vinyl alcohol (EVOH) copolymer.
Without EVOH, Exactech’s knee and ankle inserts could be exposed to oxygen. Over time, oxidation can damage inserts’ durability, leading to unexpected wear, bone loss, and total product failure.
|Exactech’s Total Knee and Ankle Replacement Device Recalls|
Exactech is recalling tibial inserts and liner components from the following knee and ankle replacement systems:
You can check whether your Exactech implant has been recalled by entering your device’s serial number into Exactech’s Polyethylene Patients recall portal. If you do not know your implant’s serial number, contact your surgeon for more information.
Exactech’s Connexion GXL Hip Liner Recall
Exactech Connexion GXL Hip Liners are polyethylene pieces fitted in hip implant devices. However, Exactech’s hip liners have also recorded high rates of early failure, which could cause bone loss and other potentially debilitating injuries.
While Exactech says that patients who have not experienced any complications do not require further surgery, the company has already recalled 90,000 of its Connexion GXL Hip Liner inserts.
Similar to its recall of Total Knee and Total Ankle replacement devices, Exactech has only issued warnings to surgeons and other health care providers.
In other words, Exactech has not warned people who may already have been injured by its negligently packaged products.
When You Should Contact a Physician
Exactech claims that most patients who have been fitted with its knee, ankle, and hip replacement inserts will never experience side-effects.
However, Exactech has admitted that its products could be responsible for injuries including but not limited to:
- Early device failure
- Loosening of inserts and other device parts
- Bone loss
- Osteolysis, or the gradual destruction of bone tissue
- Difficulty walking
Since many of these medical signs and symptoms could be confused with general age- or lifestyle-related pain, anyone who has received an Exactech insert and developed failure-related health concerns should contact their physician immediately. Your doctor will be able to perform diagnostic tests to check whether your Exactech insert is safe for continued short- or long-term use.
However, people who have received faulty Exactech knee, ankle, or hip replacement devices may need to get corrective surgery.
How Justinian & Associates Could Help You Get Justice
The Exactech Surgical Implant Recall is a Class 2 Recall
The F.D.A. has classified this recall as a Class 2 Recall, which means that Exactech’s dangerous devices have been widely distributed and pose a serious health hazard.
Even though Exactech has confirmed that its products could cause intense pain and suffering, the company has not informed patients that their knee, ankle, or hip replacement insert could be at risk of premature failure. Instead, Exactech has passed off this responsibility to surgeons.
If your physician has informed you that your Exactech insert has been recalled, you could file a claim for damages against Exactech.
You may be eligible for compensation if:
- You have or had a recalled Exactech knee, ankle, or hip replacement device
- You have suffered pain after receiving an Exactech implant
- You have received a letter, e-mail, or other communication from your physician informing you of the recall
Exactech does not currently offer any means for patients who have suffered pain, loss of mobility, or other failure-related side-effects to recover damages for their injuries and losses.
The Law Protects People Injured By Hazardous Medical Products Like the Exactech Implants for Hip, Knee and Ankle Surgery.
Unfortunately, the thousands of families and people who trusted Exactech’s product may face even greater health concerns, including ongoing treatment and the medical bills and lost time that comes with it.
If you or a loved one was injured, you may be legally entitled to money to cover your financial and physical injuries. Speak to a personal injury attorney who can advise you on how to proceed.
An Austin Personal Injury Law Firm That Knows What You’re Up Against
Exactech Lawsuits Can Be Very Complex to Prove
Winning a mass tort lawsuit for injuries caused by hazardous products or dangerous pharmaceuticals usually involves proving that the manufacturers did not properly warn people taking it of the potential risks.
That can include investigating medical studies, corporate publications and using testimony from experts on how the medication caused an injury. This is not easily done, particularly when drug companies show up with an army of lawyers.
But battling bullies is what Justinian & Associates does.
We Are Warriors For The Injured
That’s exactly why we were founded.
We have extensive knowledge of that area of law, along with the experience, the resources, experience and trained investigators to take on adversaries of any size.
We have extensive experience with medical device lawsuits. In fact, our leading attorney on mass torts, Amber M Pang Parra, is a leader in the field, and routinely chosen to help steer the committees that oversee and represent the interests of thousands of injured patients.
She understands the personal and real world challenges that a client faces when a dangerous medical device or other consumer product is recalled and determined to be dangerous. She is a dedicated attorney with a record of receiving compensation for thousands of injured clients.
And while every case is different, Amber understands what it takes to win.
All we do is fight for injured victims.
The Time to Act is Now
Your rights can be lost if you wait.
There are laws that limit how much time you have to file a lawsuit after being injured. They are known as statutes of limitation. They may apply to your lawsuit to recover for your Exactech injuries. The countdown may already have begun.
The legal team at Justinian and Associates has years of experience dealing with cases like the Recall of Exactech Implants for Hip, Knee and Ankle Surgery.
The statute of limitations (how long you have to file a case) may already be counting down. Don’t let it expire!
Call, text or email us for a free consultation, with no obligation.
Speak to an Austin personal injury attorney from Justinian & Associates (not a “screener” or paralegal) to understand your rights.