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Exactech Implant

Exactech Lawsuit

Our lawyers are handling Exactech recall lawsuits across the country.  Our law firm is accepting Exactech knee, hip, and ankle implant failure cases from victims who had a recalled Exactech implant system that subsequently failed, requiring revision surgery. Exactech recall suits are filed in an Exactech multi district litigation in New York and state courts in Florida among other places

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Exactech Recall Lawsuit

Exactech has recalled thousands of knee, hip, and ankle implants. Most patients calling our Exactech lawyers have received a letter from their doctor about the recall and want to bring a claim because they have gotten or will soon need revision surgery.

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.

Knee surgery patients with an Exactech knee implant that failed and need revision surgery may be entitled to bring a lawsuit. Our clients are filing Exactech lawsuits seeking financial compensation for their pain and medical expenses. Because the pain and suffering and other harms victims will endure were the cause of an unnecessarily defective product.

Exactech Lawsuit Update: January 20, 2023

The Judge in the Exactech implant recall MDL will hold a status conference next week at which he is expected to set deadlines for the parties to provide joint discovery and case management plans.

On Tuesday, lawyers for both sides submitted a joint status report to Judge Garaufis outlining their progress on specific administrative tasks and the status of discovery in the 86 consolidated cases in Florida state court.

The report notes that master discovery requests by the plaintiffs in the Florida cases were served in early December. The deposition of Exactech's leading medical officer (Dr. Sharat Kusuma) is set for February 16, 2023.

Exactech Lawsuit Update: January 14, 2023

Hursey v. Exactech, Inc. et al. (1:22-cv-07893) is another excellent example of a recent Exactech implant recall lawsuit filed in the Exactech recall class action MDL in the Eastern District of New York.

The implant product in the case is Exactech's Truliant Knee System, which was recalled in February 2022. Hursey had the Truliant implanted during knee replacement surgery in July 2021, and by August 2022, the polyethylene insert component had already failed, requiring revision surgery.

Hursey primary cause of action in the lawsuit is strict liability based on a manufacturing defect, but several other claims are asserted.

Exactech Lawsuit Update: January 9, 2023

An excellent example of a recent Exactech recall lawsuit filed in the Eastern District of New York is Hursey v. Exactech, Inc. et al. (1:22-cv-07893). The case involves Exactech's Truliant Posterior Stabilized Knee System.

Mr. Hursey had the Truliant system implanted during knee replacement surgery.  He was later forced to undergo revision surgery due to worsening pain and swelling. During that revision surgery, it was discovered that Hursey's pain and swelling were due to premature failure of the polyethylene insert in the Trulia.

Hursey's Exactech recall lawsuit asserts multiple causes of action against Exactech, with the primary theory being strict liability based on defective manufacture.

Exacteh Lawsuit Update: January 7, 2023

new study is planned to follow up on patients who have received or will receive a Truliant knee prosthesis.

Exactech Lawsuit Update: January 1, 2023

In addition to the Exactech recall lawsuits pending in the federal court MDL, there are now 80 Exactech lawsuits pending in a state court version of an MDL in Florida.

Last week, lawyers for Exactech sent a letter to MDL Judge Garaufis stressing the importance of coordinating the discovery in federal and state court actions. To that end, Exactech filed a motion in the Florida proceedings seeking federal-state discovery coordination. The plaintiffs' Exactech lawyers are opposing this motion.

Exactech Lawsuit Update: December 27, 2022

At the initial status conference in the new Exact implant recall MDL, Judge Garaufis agreed with the plaintiffs that the measures should be taken to get caught up to the Exactech state MDL already underway in the Florida courts. At the end of last week's conference, Judge Garaufis granted the request to allow new Exactech recall cases to be filed directly in the MDL.  This makes it easier for everyone.

He also issued several expedited deadlines for the initial MDL housekeeping measures. The judge formally approved the appointment of 27 lawyers to serve in various positions on the plaintiffs' leadership committees for the litigation. There will be an executive committee, liaison counsel, and a plaintiffs' steering committee.

Exactech Lawsuit Update: November 18, 2022

The initial status conference in the Exactech implant recall MDL in federal court will be this week. There is already a state court version of an MDL ongoing in the Florida court system.

The Florida state MDL is already far ahead of the federal MDL in terms of time frame, with an initial bellwether test trial set for next year. This has prompted many lawyers on both sides to urge the judge in the federal MDL to expedite the process to catch up.

In a pair of letters to Judge Nicholas G. Garaufis, separate plaintiffs' Exactech attorneys have asked that he immediately permit direct filings in the federal MDL and to name lawyers to the plaintiffs' leadership committee.

Exactech Lawsuit Update: November 8, 2022

The Exactech implant recall lawsuits in the federal court system were recently consolidated into a new class action MDL. Meanwhile, 50 Exactech lawsuits involving recalled hip and ankle implants have been filed in Florida state courts and consolidated into a state version of an MDL class action.

An Exactech lawsuit in state court may go to trial before the federal class action. The judge presiding over the consolidated Exactech state court suits in Florida issued an Order scheduling the first trial for November 2023. This trial will function like a de facto bellwether test trial for all Exactech lawsuits.

Exactech Lawsuit Update: October 11, 2022

The JPML has officially consolidated the Exactech joint replacement recall lawsuits into a new class action MDL. All lawsuits involving the recalled Exactech knee replacement or ankle replacement implant systems will now be centralized in the Eastern District of New York.

The MDL has been assigned to Judge Nicholas G. Garaufis. Judge Garaufis is a Senior Judge appointed to the bench in 2000 by President Clinton.

Exactech was not opposed to the consolidation, but the joint replacement company had been pushing for the MDL to be created in the Northern District of Florida, where its headquarters is located. The Exactech recall cases will now proceed through a consolidated discovery process overseen by Judge Garafis.

With a new class action MDL on the horizon, the pace of new Exactech implant recall lawsuits has rapidly accelerated. Since June 1st, 75 new recall lawsuits have been filed against Exactech in federal courts. Many of these new cases are being filed by groups of multiple plaintiffs. The Eastern District of New York continues to be the most popular forum, with 75 new cases filed in that venue. Our Exactech lawyers, not coincidentally, are getting many clients who had surgery at the Hospital for Special Surgery in New York City.

Exactech Lawsuit Update: September 1, 2022

The U.S. Judicial Panel on Multidistrict Litigation will hear on September 29, 2022, arguments on whether to consolidate federal lawsuits alleging Exactech joint failures from manufacturing and design errors into a class action lawsuit. Certifying and MDL and bringing together all of the lawsuits is a huge step forward on the path to victims receiving fair settlement amounts for the harm that has been done to them from mistakes that led to the Exactech recall.

Exactech Lawsuit Update: August 22, 2022

The Exactech recall just got bigger. Exactech was forced to expand the scope of its hip and ankle replacement implant recall. Exactech sent a new recall notice letter to healthcare providers last week advising that the implant recall initiated in February was being expanded to cover another 40,000 acetabular hip liner components in the company's Connexion, Novation, and other brand implant systems.

This expanded recall comes as the JPML ponders whether to consolidate the growing wave of Exactech implant recall lawsuits into a new class action MDL. Our lawyers struggle to envision a scenario where a new Exactech class action lawsuit is not formed. We expect the court to rule as early as this month.

Exactech Lawsuit Update: August 1, 2022

Lawyers for implant manufacturer Exactech submitted a response to the recent MDL motion filed with the JPML. Exactech advised the panel that supports consolidating all Exactech implant recall lawsuits in federal court into a new MDL. Exactech also agreed with the plaintiffs' venue preference in the Eastern District of New York. This should guarantee that the JPML will agree to form a new Exactech class action lawsuit for these recall cases.

Exactech Lawsuit Update: July 1, 2022

It has been nearly four months since Exactech announced a sweeping recall of all its knee and ankle replacement implant systems. But most patients who received the defective implants have still not received any notification about the recall.

When the recall was first initiated in February, Exactech provided orthopedic surgeons with a form letter to send out to patients notifying them about the recall. Beyond providing this sample patient letter, however, Exactech has made no further efforts to reach out to patients. There are an estimated 150,000 patients with defective Exactech implants, and only a tiny percentage of them have been notified of the recall.

So there is no Exactech class action lawsuit and the pace of new recall claim lawsuits remains comparatively slow. A total of nine new product liability lawsuits were filed against Exactech in federal courts during May. Only nine Exactech recall cases were filed in April.

The Exactech recall covered an estimated 150,000 patients. But a large percentage of these patients remain entirely unaware of the recall because Exactech has left it up to individual doctors' offices to send out notification letters to patients. Look for a significant uptick in the number of Exactech recall lawsuits getting filed by the end of the summer.

This slow pace is delaying the inevitable Exactech class action lawsuit to deal with all of these lawsuits together. Exactech lawyers were waiting until there are enough lawsuits filed to go to the MDL Panel and seek a class action.

Late last month (June 2022), a group of Exactech knee implant recall plaintiffs filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) for a new MDL Exactech class action lawsuit to be established for the consolidated handling of all future Exactech recall lawsuits.

The Exactech recall announcement in February has led to a steady stream of product liability lawsuits by patients who had defective knee and ankle replacements implanted. According to the motion filed with the JPML, there are currently 27 Exactech implant recall cases pending in 11 different federal districts.

The motion suggests the Eastern District of New York as a possible venue for the Exactech class action lawsuit. But Exactech will most likely request the Northern District of Florida where its headquarters is located. (Update: New York won out.)

Recall of Exactech Knee and Ankle Replacement Implants

Exactech is a global medical device company headquartered in Gainsville, Florida. Since it was founded in 1985, Exactech has specialized in surgical implant systems for use in joint replacement surgeries.

In August 2021, Exactech initiated a sweeping nationwide recall of all its knee replacement and ankle replacement implant systems manufactured after 2004. The recall impacts almost 150,000 knee replacement implants in the U.S. The Exactech implant systems are used in knee replacement surgery, referred to as total knee arthroplasty (“TKA”). TKA knee replacement surgery is used to relieve severe pain associated with arthritis and is also used to correct knee trauma and deformities.

These are the recalled Exactech products:

System Release Date
OPTETRAK Logic® 2009

Exactech launched the recall after learning that a defect in the vacuum-seal packaging of its knee replacement systems was causing the polyethylene insert component to oxidize before use. Polyethylene is an important part of TKAs.  But these inserts cannot be exposed to oxygen during the packaging and storing process.  Exposing polyethylene inserts to oxygen creates a chemical reaction called oxidization, which causes the premature wear or degradation of polyethylene inserts.

So polyethylene inserts must be handled with a high degree of care when processed, packaged, and stored. If they are exposed to oxygen… what will happen is what did happen for many reading this. How does a TKA feel when the insert degrades?  The patient's knee loses its ability to function properly in the knee replacement system and the patient feels discomfort and a loss of function.

So, over time, the degraded polyethylene inserts cause excessive friction and wear. This causes the premature failure of the Exactech knee replacement systems. The result is often the need for premature revision surgery.

Patients who experienced failure of their Exactech knee replacement system due to this manufacturing defect experienced significant pain and lack of mobility in their knees. Eventually, failure of the knee replacement system requires the patient to undergo corrective revision surgery. No one who has had knee surgery wants to do it again.

What Should Patients with Recalled Exactech Implants Do?

Exactech sent out a letter to doctors regarding the recall. The letter instructs surgeons to immediately stop using Exactech implants in all knee and ankle replacement surgeries. Doctors and hospitals are also instructed to return their existing inventory of recalled devices for replacement. As far as their letters go, this was a pretty honest letter. Exactech is falling on its sword and admitting the problem.

As for surgery patients who already have an Exactech knee replacement system implanted, the recall letter instructs them to consult with their doctors. Doctors are advised to maintain an index of all patients with Exactech implants and closely monitor them for signs of potential insert failure.

Exactech also provided doctors with a draft letter to send to their patients – you may have received that exact letter – explaining the basis for the Exactech recall which is not very different from what our lawyers explained above.

If you have an Exactech knee or ankle replacement implant system, signs that the implant may have failed due to the defective insert include pain and swelling, inability to bear weight on the joint, grinding in the joint, or instability in the knee or ankle. Surgeons are instructed to take X-rays when a failed implant is suspected to evaluate the status of the Exactech implant.

Exactech Knee Replacement Implant Lawsuits

Medical device manufacturers like Exactech have a legal obligation to ensure that their products are safe when used for their intended purpose and free of any harmful flaws or defects. The Exactech recall notice effectively admits that the Exactech knee and ankle replacement implants were defective. So holding Exactech liable for injuries and damages the result will be less of a challenge than you would ordinarily have in a typical class action lawsuit.

Anyone who had an Exactech knee replacement implanted after 2004 may be able to bring a product liability lawsuit if that implant subsequently failed and they had to undergo revision surgery. Plaintiffs who bring a successful Exactech knee recall lawsuit would be entitled to damages for (a) pain and suffering; (b) medical expenses incurred in treatment and corrective revision surgery; (c) and any lost income or wages incurred as a result of the knee implant failure.

Our lawyers believe that if you have a viable claim, you are much more likely to get an Exactech settlement than you are to see the inside of a courtroom.  Because the evidence of the mistakes Exactech made not just coming from plaintiffs' lawyers.  The strength of these cases are the admissions made by Exactech after the recall.

History of Problems with Exactech Knee Implants

The Exactech knee replacement system has a long history of high failure rates and other problems. Exactech has always obtained 501(k) abbreviated FDA clearance for its knee replacement systems to avoid the full FDA review and approval process. From the very beginning, Exactech was aware that its OPTETRAK knee replacement implant system had a significantly higher failure rate compared to other devices.

Reports on Exactech implants in the FDA's Manufacturer and User Facility Device Experience (MAUDE) indicated the devices were failing at an abnormally high rate compared to other implants. This early onset failure MAUDE reports are representative of the increased rate of incidents of which Exactech had become internally aware several years ago. There are currently so many complaints about Exactech implant devices in MAUDE that a search maxes out (at 500). So it cannot show all the Exactech complaints.

These failures prompted product liability lawsuits in 2016-2017 against Exactech by users who experienced premature implant failures. Our lawyers have gone back and read those lawsuits. The attorneys who filed those lawsuits did not understand why Exactech knees were failing. They were hovering around the problem. But these Exactech attorneys did not – because they could not – fully understand why Exactech knees were failing.

These early Exactech implant lawsuits did understand that the high failure rate of these component parts was related to the “finned” design feature that is unique to the Exactech implants. These knee replacement lawsuits accused Exactech of failing to warn consumers about this risk and instead pursued a “silent” recall in which they slowly replaced the finned design without recalling them. But the Exactech recall shed light on the specific oxygenation problem that caused these component parts to wear down.

Exactech's phasing out of the finned design failed to reduce the abnormally high failure rate on their implant systems. This eventually led them to investigate other possible flaws which led to the discovery of the defective vacuum-seal packaging that prompted the recall notice.

Exactech Obtained Fast-Track FDA Approval

Exactech repeatedly obtained 501(k) clearance from the FDA for its Optetrak, Optetrak Logic, and Truliant total knee replacement implant systems and components between 1994 and 2017.

This 501(k) clearance from the FDA is called “fast-track” approval because it does not require the manufacturer to prove the safety and effectiveness of a product. This path, also called “premarket notification”, of 510(k) clearance only requires the manufacturer to explain the device's substantial equivalence to a pre-MDA predicate device.

The FDA may then “clear” the new device for sale in the United States. All the component parts comprising Plaintiff's Optetrak Device were cleared for marketing by the FDA under the 510(k) process or were marketed without receiving either 510(k) clearance or full approval by the FDA.

Our Exactech Lawyers Are Seeing Exactch Opterak Lawsuits

Exactech's leading knee replacement implant is the Optetrak Total Knee System. In the first three months of the recall, more than half the calls from victims our Exactech lawyers have had involved Opterak. So we will focus a bit on Opterak for a moment although most of what our attorneys say about the merits of the Operterk claims apply to all Exactech lawsuits.

The Opterak is classified as a knee joint patellofemorotibial semi-constrained cemented prosthesis. It features a mix of polyethylene and metal-based components. The Optetrak is comprised of the following parts: a patellar cap, femoral cap, tibial insert, and tibial tray, as we show above. The patellar cap and tibial insert are made of polyethylene.

Exactech Lawsuits Question Opterak Marketing

Exactech marketed the Optetrak as “first-in-class” and its product materials and claims that the Optetrak had excellent long-term clinical outcomes. Exactech promoted the Optetrak as a system with nearly three decades of clinical success and proven outcomes for patients because of an improved design resulting in low stress on the polyethylene insert components.

In truth, however, Optetrak has performed poorly when compared to its competitors. For example, the Australian Orthopaedic Association, a preeminent, internationally recognized orthopedic implant registry, has identified the Optetrak as an implant with a higher-than-expected rate of revision. According to the 2020 Australian National Joint Replacement Registry, the rate of revision for a total knee replacement utilizing an Optetrak far exceeds international guidelines for accepted revision rates.

Exactech was aware of the high early failure rates with the Optetrak implants from the very beginning. As early as 2012, Exactech had indisputable clinical evidence that the Optetrak knee implants were failing at a much higher rate than Exactech claimed in its marketing materials. By that time, reports of early failure and revision associated with the Optetrak implants had started to accumulate in the FDA's MAUDE database. These adverse incident reports indicated similar reasons for premature revision with the Optetrak, all of which indicated that there was a problem with the implants.

Exactech Sales Reps Aware of Opterak Problems

The general practice at Exactech (as with most orthopedic implant manufacturers) is to have their authorized sales reps present at the time of surgery to provide implant components to the surgeon. This practice relieves the hospital of the responsibility for having in stock all potential sizes and components that may be needed in surgeries. Exactech sales reps were present for both original implant surgery and any revision surgery.

Exactech sales reps observed first-hand countless cases of premature failures of the Optetrak. They witnessed clear evidence of premature degradation of the plastic inserts, which was often noted by the surgeons as well. Often these sales reps would take the component from the surgeon to return to the company for inspection and analysis.

The Exactech sales reps were under a duty to report these findings to the engineering and medical departments of Exactech who were under a duty to then do an investigation, analyze the removed component when available (also known as retrieval analysis), and honestly and thoroughly report such findings to the FDA and the surgeons. This did not happen. Exactech's sales reps reported the issues to the company. But Exactech continued to promote and sell the implants without alerting surgeons, patients, or the FDA of the growing evidence that the Optetrak was prone to premature failure.

Despite being aware of the problems in 20212, Exactech never changed the labeling, marketing materials or product inserts to adequately and accurately warn patients or physicians of the associated increased risks of early failure of the Optetrak. It was not until August 2021 that Exactech finally took action by initiating a safety recall of the Optetrak and other implant systems.

Exactech May Have Intentionally Concealed Opterak Problems

Exactech put out a Dear Doctor letter when announcing the recall.  So is this just a good company that made an honest mistake and owned up to it?  Not quite.

There is ample evidence that Exactech and its corporate executives were well aware that the Optetrak knee implant system was defective. There is no dispute that Exactech knew that the Optetrak implants had an abnormally high rate of early failure and complication and a greater propensity to wear out prematurely compared to other implants.  But that did not trigger a recall for years.

Exactech May Have Hid Concerns Before Selling Company with Optertak and Other Implants

All indications are that Exactech knew about the issues with Optetrak by 2012 or 2014 at the latest. By that time, however, Exactech's founders may have already been looking to cash out by selling the company. In 2017, it was announced that a private equity company called TPG Capital was in the process of acquiring Exactech.

TPG's acquisition of Exactech was finalized in February 2018. TPG bought out all the outstanding shares of Exactech stock for $49.25 a share, effectively converting Exactech from a public company to a privately held company.

It was only a few years after Exactech went private through the TPG acquisition that the company finally took the long-overdue step of recall of its knee and ankle implants. Had the recall been initiated before Exactech went private, it would have had a crushing impact on their stock and possibly led to various lawsuits by shareholders.

Example Exactech Logic Knee Implant Lawsuit

One of the first post-recall Exactech knee replacement lawsuits was filed in federal court in New York. The case, Burke v. Exactech Inc., 1:22-cv-020806 (S.D. NY), was filed on March 14, 2022. The plaintiff, James C. Burke, had the Exactech Optetrak Logic implanted in his left knee in 2013 and another one implanted in his right knee two years later. Burke's Optetrak Logic implant only lasted a short time and the complaint claims that he suffered pain, instability, and bone loss in the years following the surgery. Eventually, Burke underwent extensive revision surgery in 2019. She hired a personal injury lawyer to bring an Exactech recall lawsuit.

The product liability claims in Burke's Exactech lawsuit rely heavily on Exactech's February 2022 recall announcement of all Exactech knee and ankle replacement implant systems. The Burke complaint cites the recall based on the defective packaging and premature wear of the plastic liner inserts as evidence that the Optetrak implant was defective. He claims Exactech knew about these defective inserts and negligently failed to warn doctors and patients. Burke's Exactech recall lawsuit asserts that the premature failure of his Exactech knee implants after just six years was a direct and proximate result of “accelerated polyethylene wear” in the Optetrak inserts.

The Burke complaint asserts ten separate counts. But the primary theory of tort liability in the complaint is strict liability based on a manufacturing defect. Burke is seeking compensatory damages for his medical expenses and pain, as well as punitive damages.

What Is the Current Status of the Exactech Recall Lawsuits?

In January 2023, the federal Exactech multi district litigation and state court cases in Florida are operating on parallel tracks pushing towards trials dates in late 2023 or early 2024.

File Your Exactech Recall Lawsuit

If your Exactech knee replacement implant failed and you had to undergo corrective surgery, contact our legal team today at 800-553-8082 to see if you have a case. You can also get a free case evaluation online.

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