Exactech Lawsuit: Recall of Knee, Ankle and Hip Devices
In February 2022, Florida-based medical device company Exactech issued a recall on over 150,000 knee, ankle and hip replacement devices. If you or a loved one has received a knee replacement, hip replacement, or ankle replacement since 2004, one of these non-conforming devices may have been used in your procedure. If this is the case, you may be at risk of premature wear on the devices or bone loss. You may even need revision surgery. If you are among the thousands of Americans in this position, you should reach out to an Exactech recall lawyer, as you may be eligible to join an ongoing Exactech lawsuit.
Exactech is a well-established manufacturer of medical technology, and its replacement devices have been used in thousands of procedures across the country. In 2021, however, the company discovered that thousands of parts used in ankle, knee and hip replacement surgeries since 2004 were packaged with a non-conforming vacuum bag, causing a reduction in the shelf-life of the polyethylene constituents. The faulty devices do not contain the technology required to ensure their longevity. They are likely to wear out earlier than they are supposed to, meaning that the patients will need to undergo continued or renewed medical procedures. This will lead to ongoing medical costs, as well as the pain, discomfort and possible lost income that will result from the necessary operations and subsequent recovery time.
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Exactech Lawsuit FAQs
Who is affected by the Exactech recall?
The Exactech recall could potentially affect any individuals who have received one of the recalled devices in ankle, knee, or hip operations since 2004. The recall does not affect all of Exactech’s knee, ankle and hip replacement products. Four product lines have been affected. If you have not heard from your surgeon yet, letting you know whether or not you have been affected, you should reach out to your healthcare provider as soon as possible and see where you stand.
What implants are impacted by the Exactech Recall
Four Exactech products have been targeted in the successive recalls issued in 2021 and 2022, including knee, ankle and hip implants. They are as follows:
Exactech’s Optetrak and Optetrak Logic knee replacement devices have gone through several recalls since 2011. In 2013, Exactech introduced a redesigned version of the implant, discarding the finned tibial tray and creating a more stable version of the device. The newer, fitted tray has produced much more positive results, but there are still thousands of people who have the old design and may be at risk of future knee problems.
The Truliant Knee System was also recalled, as the devices had not been adequately packaged, and the manufacturer is concerned that this could lead to product deterioration.
In October 2021, Exactech issued a recall on its Vantage total ankle system. The main reason was that the devices had been packaged in vacuum bags that did not provide an effective oxygen barrier layer. This has affected the stability and longevity of the devices. The company recalled all Vantage units that had not been packaged in EVOH/nylon bags. The units are supposed to have an 8-year shelf life, but this may have been diminished as a result of the faulty packaging. Unfortunately for those patients who have received these implants, the devices may deteriorate early and need revision or replacement.
In February 2022, Exactech issued a recall on its Connexion GXL Acetabular Liners. These devices are used in hip replacements. The recall stated: “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.”
What can occur if my Exactech device is failing?
If your Exactech device is among the recalled units, there is a possibility that you could experience one or more of the following complications:
- Inability to bear weight on the affected joint
- Grinding or scraping noises
- Pain in or around the affected, hip, knee or ankle
- Premature wear
- The need for revision surgery
What should I do if my Exactech device is recalled?
If you are among the patients who have received any of the recalled parts since 2004, you should first contact your healthcare providers for an evaluation. You can either consult with the surgeon who performed the operation or your current family healthcare provider, who can refer you to the relevant specialist if necessary. Healthcare professionals who have received the recall letter from Exactech should actually reach out to the affected patients and enquire whether the devices are still working or if any further investigation is required. As a patient, it is best to be proactive and contact your doctor or surgeon first, if they have not already done so. If you are experiencing any of the complications listed above, it is particularly important that you consult with a medical professional as soon as possible, but it is advisable to do so, even if your device currently appears to be working perfectly, and you are not experiencing any pain or discomfort. Once your surgeon has confirmed that you have a recalled implant, you can lodge a claim with Exactech itself so that the company can reimburse you for recall-related out-of-pocket expenses. If you are experiencing complications, and your healthcare professional recommends revision surgery, you should most certainly consult with an Exactech recall lawyer and see if you qualify to join the ongoing Exactech recall class action lawsuit.
Do I qualify for the Exactech recall lawsuit?
If you are among the many thousands of Americans who received one of the recalled Exactech devices since 2004, and you have suffered any of the complications listed above, you may qualify to join the lawsuit. Consult an Exactech recall or class action lawyer to see if you are eligible. The exact criteria to qualify are as follows:
- You received an implant of an affected/recalled device between 2004-2022.
- You require revision surgery with noted complications, or have already undergone revision surgery.
- The original implant took place at least one year before revision surgery.
- Revision took place within ten years of the original implant.
- There is evidence of polyethylene wear/failure at revision.
- The need for revision results from a failure in the device itself and not an unrelated infection or trauma.
Will I need revision surgery if I have an implant that has been recalled?
Exactech does not recommend revision surgery for patients who are not experiencing any pain, difficulty walking, or other complications. If you are experiencing these problems, you may need revision surgery. The only way to know for sure is to consult a healthcare professional.
What will the settlement offer cover?
The settlement could cover any medical treatment, including surgery costs, after your device replacement device fails. Medical expenses (past and future) Pain and suffering (past and future) resulting from injuries, treatment, and recovery, could also be included. While it is currently uncertain exactly what type of settlements can be expected when you successfully file a suit against Exactech, it is possible to make a general estimate. The average compensation for knee injury tort cases is $110,000, but Exactech recall cases may well result in a higher amount being awarded. Juries are likely to be relatively unsympathetic to a major medical device company that has placed thousands of patients at risk through sub-optimal design and packaging protocols. Punitive damages are likely to be a factor. All things considered, settlements could reach between $200,000 and $300,000.
What is the claims process?
Exactech has set up a website containing all the recall information and outlining the claims process. Patients are advised to call the Exactech-Broadspire helpline. Once you confirm that you have an Exactech polyethylene insert, a claim is started and a representative will get back to you with all the necessary information, more advice on how the reimbursement procedure, and all the forms you need to fill in.
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Contact Miami Exactech Recall Lawyers about the lawsuit
If you feel you qualify to join the recall lawsuit, contact an Exactech recall lawyer and book a consultation. Once you explain the specifics of your case, we will be able to tell you whether you are eligible to join and get the process underway.
About Shamis & Gentile
distinguish ourselves because of our experience and resources, which we combine to handle any kind of case involving personal injury, personal injury protection, class actions/mass tort, and contract disputes. When you bring your case to Shamis & Gentile, you will always work with a seasoned attorney who has an excellent track record. We are progressive and trusted within the legal community and we are often called upon to settle cases that other law firms may not be able to handle on their own. With us, you can rest assured that your Exactech recall case is in safe hands.
We are now investigating Exactech recall cases and we invite you to call us today at 305-479-2299. Let us know how you may qualify to pursue an Exactech recall lawsuit, and our team of Exactech recall lawyers will review your information and advise you on how to proceed.