The company Exactech helps surgeons worldwide make patients more mobile with innovative instruments, implants, and technologies for joint replacement.  From the year 2021, the Exactech company have been recalling many of its knee, hip, and ankle implants. Naturally, most patients will now have to undergo surgery again and want to bring the claim for the same.
“Medical device company Exactech recently announced a major recall of all its knee (and ankle and hip) replacement implant systems made after 2004. This recall came after discovering that defective packing was causing a polyethylene insert component to degrade. This packaging defect caused many Exactech knee implants to fail prematurely. This replacement failure has forced and will force many patients to undergo unnecessary corrective surgery.”
Lawsuit Update as of February 20th, 2023: “The judge in the Exactech recall class action MDL has scheduled a “science day” for May 10th. Science days are common in mass tort MDLs involving product liability claims. They give lawyers for each side the opportunity to make presentations designed to educate the court on the scientific issues and evidence involved in the litigation. There are now 132 cases pending in the Exactech MDL, and at least 80 pending in Florida state courts.”
“On August 11, 2022, Exactech warned surgeons that even more devices may be impacted by the defective bags than the company originally thought. The U.S. Food and Drug Administration (FDA) classified this action as a class II recall. This means that exposure to the product may cause temporary or medically reversible health consequences, or the probability of serious health consequences is remote.” 
Complications Resulting from Exactech knee replacement: “Exposure of the knee replacement device to oxygen prior to being implanted in the body can cause oxidation, which means the plastic can wear out earlier than expected or become damaged in the patient’s body — essentially causing knee implant failure. Symptoms patients may experience include:
- Knee swelling
- Pain while walking
- Inability to bear weight on your implant
- Grinding or clicking
- Overall instability
Unfortunately, premature wearing of the plastic insert can lead to the need for revision surgery. If you or a loved one had knee surgery with an Exactech insert, you have legal options, and an Exactech knee replacement lawsuit attorney at Searcy Denney can help determine if you qualify for compensation.” It is very evident that the company might have known about the defect of their products. Here’s Why: “The U.S. Food and Drug Administration (FDA) began receiving adverse event reports related to Exactech’s knee replacement devices at least as early as 2017. Thus, the company should have been aware of potential safety concerns related to its knee replacement devices at this time as well.”
“There haven’t been any Exactech lawsuit settlements or jury verdicts in the current knee, ankle and hip implant cases. Lawyers are still accepting clients and the litigation is in the early stages. Exactech has hired a third-party claim settlement company called Broadspire, but it isn’t the same as being awarded a settlement in a lawsuit. They won’t replace your failed implant for free or let you go to your doctor for free. Broadspire will be reimbursing you for money you have already spent and won’t include future care costs or lost wages.” 
Past Exactech Litigation: “The current Exactech lawsuits aren’t the first time the company has been involved in litigation over its joint replacements. They’ve been sued by the federal government and the state for questionable business practices related to their implants. Most recently in 2020, whistleblowers sued Exactech under the False Claims Act, claiming the company knowingly provided faulty knee replacements to VA, Medicare and Medicaid beneficiaries. The Department of Justice sued Exactech for paying orthopaedic surgeons to cause providers to use Exactech’s hip and knee implants from January 2002 to December 2008. This resulted in false claims being submitted to Medicare. The case was settled in 2010.” 
“Prior to the current recalls, Exactech has faced problems with its joint 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 revision surgery rates increased as high as seven-fold compared to other devices. It has also faced a whistleblower lawsuit that say the company knowingly giving faulty knee replacement devices to Medicare, Medicaid, and Department of Veterans Affairs beneficiaries.”
- In the case of United States ex rel. Wallace Vs. Exactech, Inc., a qui tamaction brought by Relators on behalf of the United States, 23 states, and themselves against Defendant Exactech, Inc. (“Exactech”), a medical device manufacturer. Relators accuse Exactech of violating and conspiring to violate the federal False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq., and corresponding state FCAs by knowingly causing false claims to be submitted to federal and state healthcare programs for defective replacement knee devices surgically implanted by unsuspecting physicians and by using false statements material to those claims. Relators also allege that Exactech violated the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b, and the FCA by paying remuneration to physicians who suspected the defects in order to induce them to continue to buy Exactech products.”
- In the above case states that if a pleading states a claim for relief must contain a short and plain statement of the claim showing that the pleader is entitled to relief”. R. Civ. P. 8(a)(2). However, the facts alleged in the complaint must be specific enough that the claim raised is “plausible.” See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
- In the case of Resnick Vs. AvMed, Inc., held “To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim for relief that is plausible on its face.”) A claim for relief is plausible on its face when the complaint’s “factual content . . . allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”
- “Exactech argues that the Amended Complaint is an impermissible shotgun pleading that should be dismissed with prejudice since Relators have already once failed to cure the complaint’s deficiencies. Additionally, Exactech argues that Relators have failed to state a claim under Rule 9(b)and Rule 12(b)(6).”
- In the case of Ziemba v. Cascade Int’l Inc., 256 F.3d 1194, 1202 (11th Cir. 2001) (quotation omitted). “Rule 9(b) must not be read to abrogate rule 8, however, and a court considering a motion to dismiss for failure to plead fraud with particularity should always be careful to harmonize the directives of rule 9(b) with the broader policy of notice pleading.”
If you received any replacement mentioned above by implants produced by Exactech. First and foremost, you need to contact a medical professional who will guide you through next best steps to take. In addition to this, contact a personal injury lawyer to discuss your legal options.
 About Exactech | Company Information | History  Exactech Knee Replacement Lawsuit | February 2023 Update (millerandzois.com)  Ibid.  Exactech Knee, Ankle & Hip Replacement Lawsuit (October 2022 Update) (anapolweiss.com)  Exactech Knee Replacement Lawsuit Attorney | Exactech Knee Implant Recall (searcylaw.com)  Ibid.  Exactech Lawsuits | Hip, Knee and Ankle Replacements Claims (drugwatch.com)  Exactech Lawsuits | Hip, Knee and Ankle Replacements Claims (drugwatch.com)  Exactech Replacement Recalls | Hip, Knee and Ankle Units (drugwatch.com)  United States ex rel. Wallace v. Exactech, Inc., 2:18-cv-01010-LSC | Casetext Search + Citator  Ibid.  Ashcroft v. Iqbal, 556 U.S. 662 | Casetext Search + Citator  Resnick v. Avmed, Inc., 693 F.3d 1317 | Casetext Search + Citator  Refer Footnote 1.  Ziemba v. Cascade Intern., Inc., 256 F.3d 1194 | Casetext Search + Citator
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