Exactech Replacement Lawsuits
People filed Exactech lawsuits after the company recalled thousands of hip, knee, ankle and shoulder devices in 2021, 2022 and 2024 due to defective packaging. According to lawsuits, the defective packaging caused devices to fail early, leading to additional surgery.
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- Defendant
- Exactech
- Injuries in Lawsuits
- Pain, stiffness, loosening, device failure (and revision surgery), limited range of motion and osteolysis
- MDL
- U.S. District Court for the Eastern District of New York, MDL No. 3044
- Settlements/Verdicts
- None yet
Latest Exactech Lawsuit Updates
As of November 2024, there were 1,806 pending lawsuits in multidistrict litigation before the U.S. District Court for the Eastern District of New York. Judge Nicholas G. Garaufis presides over the MDL.
There have been no bellwether, or test, trials in the MDL, though they are set to start in September 2025. Lawsuits are in the initial stages, and the number of lawsuits has been steadily increasing as lawyers accept new cases.
On Oct. 29, Exactech filed for bankruptcy in response to the mounting lawsuits. Ongoing litigation was paused as a result of the Chapter 11 filing.
Updates in Exactech Lawsuits
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October 2024:
Exactech has filed for bankruptcy in response to the mounting litigation against the company. As part of the bankruptcy filing, ongoing lawsuits against Exactech have been paused. This will naturally slow down the progress of litigation. We will keep a close eye on the bankruptcy proceedings.
Earlier this month, the schedule for the bellwether trials in the Exactech MDL had once again been modified. The Tarloff trial was set to start on Sep. 29, 2025, with the Larson trial beginning on Nov. 10, 2025. Judge Garaufis also delayed the scheduling of future bellwether trials beyond those two cases. Exactech's bankruptcy may further impact these dates. -
August 2024:
There hasn’t been much to report on for updates to the Exactech litigation over the last couple of months, according to our research of the MDL docket. However, earlier this month lawyers on both sides requested that the judge amend the bellwether trial dates. The judge proposed the first bellwether case would be Larson, 22-CV-6643, which was set to start in June 2025. The second bellwether, Tarloff, 23-CV-5793, would begin in August 2025. The trial dates were then reorganized at the end of the month. Tarloff’s trial will now start on July 6, with Larson’s trial moving to Sep. 29.
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May 2024:
Defendants agreed on David Caputo (1:23-cv-01896-NGG-MMH) as the consensus pick from the National Pool for a fourth bellwether test trial. These trial proceedings are set to start in January 2025 with jury selection potentially beginning January 2026. The third bellwether trial, Dana Kessler Kramer, is set to start October 2024 with jury selection scheduled for October 2025.
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April 2024:
Judge Garaufis set the initial bellwether trials' dates for June 2025 (Gayle Tarloff) and August 2025 (Geraldine Larson).
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March 2024:
Exactech initiated a voluntary recall on its Equinoxe reverse total shoulder (rTSA) and anatomic total shoulder (aTSA) devices to "eliminate confusion and concern in the market" and remove the devices as recommended by the FDA.
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January 2024:
The FDA announced Exactech had recalled an undetermined number of AcuMatch Hip System units after receiving complaints of loss of vacuum in the inner vacuum bag of four devices. The Class 2 recall affected devices distributed in the U.S. and 12 other countries. A status conference for the Exactech class action MDL was set for March 13, 2024, to discuss the current status of litigation, unresolved discovery matters and the selection of bellwether cases.
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January 2024:
The FDA announced Exactech had recalled an undetermined number of AcuMatch Hip System units after receiving complaints of loss of vacuum in the inner vacuum bag of four devices. The Class 2 recall affected devices distributed in the U.S. and 12 other countries. A status conference for the Exactech class action MDL was set for March 13, 2024, to discuss the current status of litigation, unresolved discovery matters and the selection of bellwether cases.
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December 2023:
Parties in the New York MDL and Exactech litigation in Florida were in the process of selecting bellwether test trials. By the end of the month, the parties planned to discuss the MDL bellwether plan.
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October 2023:
On Oct. 20, the stay on a pending transfer order from Oct. 7 was lifted and 20 more cases were transferred into MDL 3044 and are assigned to Sr. District Judge Nicholas G. Garaufis in New York.
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March 2023:
Judge Marcia M. Henry issued an order requiring all plaintiffs in the MDL to complete Plaintiff Facts Sheets before June 6, 2023.
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October 2022:
Judges consolidated Exactech cases from all over the country into multidistrict litigation in New York MDL 3044.
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June 2021:
Exactech issued a product safety alert warning that the polyethylene liners in its Connexion GXL hip systems were failing early, prompting the filing of lawsuits.
In March 2023, the FDA warned about Exactech’s joint replacement devices made between 2004 and August 2021. The packaging caused the devices to degrade earlier than expected. Many people with faulty joint replacements require additional surgery.
Why Did People File Exactech Lawsuits?
People filed Exactech lawsuits because bad packaging allowed too much air to get in and made plastic knee and ankle replacements break down too soon. Exactech recalled thousands of polyethylene hip and knee inserts in August 2021 due to the packaging problem.
In August 2022, Exactech expanded its recall to include a hip system called Connexion GXL — also due to a packaging issue that caused those devices to degrade faster than expected. By early 2024, Exactech voluntarily recalled its Equinoxe Shoulder System for the same packaging defects.
“Exactech lawsuits are being filed now because [of] premature degradation of the polyethylene inserts used in the devices.”
“Exactech lawsuits are being filed now because [of] premature degradation of the polyethylene inserts used in the devices. [The company is claiming] the root cause of this polyethylene degrading, or so they say, is that they didn’t store these implants in the right type of packaging and it needed another layer to prevent oxygen from touching the implant,” lawyer Ellen Relkin told Drugwatch.
Surgeons have implanted more than 143,000 possibly defective devices. If these devices fail early, thousands of people who received them could experience knee, ankle, shoulder and hip replacement complications.
Do I Qualify for an Exactech Lawsuit?
If you’ve had an Exactech hip, knee or ankle surgery using a recalled Exactech device and have experienced severe complications, you may be eligible to file an Exactech lawsuit against the company.
However, the criteria for eligibility vary depending on the year of your initial and revision surgery. You may not be eligible if you’ve had multiple revision surgeries before receiving the Exactech implant.
- Optetrak: All-polyethylene CR Tibial Components, All-polyethylene PS Tibial Components, CR Tibial Inserts, CR Slope Tibial Inserts, PS Tibial Inserts, HI-FLEX® PS Tibial Inserts
- Optetrak Logic: CR Tibial Inserts, CR Slope Tibial Inserts, CRC Tibial Inserts, PS Tibial Inserts, PSC Tibial Inserts, CC Tibial Inserts
- Truliant: CR Tibial Inserts, CR Slope Tibial Inserts, CRC Tibial Inserts, PS Tibial Inserts, PSC Tibial Inserts
- Vantage: Fixed-Bearing Liner Component
- Connexion GXL Liners in: MCS Hip, Novation Hip, Acumatch Hip
It’s best to consult an Exactech lawsuit attorney as soon as possible to confirm your eligibility and protect your right to file a lawsuit. They can help you understand your options and guide you through the process.
Keith Nuzzo v. Exactech Inc.
On Feb. 21, 2012, Keith Nuzzo of Litchfield, Maine, underwent a right total knee replacement utilizing an Exactech Knee Device. On Feb. 28, 2012, he underwent a left total knee replacement, also using the Exactech Knee Device, performed by the same surgeon.
Implanted Components:
The Exactech knee device used in both surgeries included the following components:
- Right Knee Replacement:
- Exactech Trapezoid Tibial Tray
- Exactech Tibial Insert
- Exactech Femoral Component
- Left Knee Replacement:
- Exactech Trapezoid Tibial Tray
- Exactech Femoral Component
- Exactech Tibial Insert
Post-Implantation & Revision Surgery:
Initially, the Exactech Knee Devices functioned as expected. In 2016 and 2020 — four and eight years, respectively, after the initial surgery — Nuzzo underwent Exactech revision surgeries due to wear, osteolysis, and aseptic loosening of components with each knee.
Current Status & Injuries:
Despite revisions, Nuzzo experiences daily pain, which limits his activities and affects his quality of life. Allegedly, defects in the Exactech Knee Devices caused permanent injuries, including pain, metallosis, soft tissue damage, and more, leading to ongoing medical needs and seeking compensation for various damages.
Conclusion:
The lawsuit aims to hold Exactech, Inc. accountable for the claimed defects in their knee replacement devices and subsequent damages suffered by Keith Nuzzo. Nuzzo’s lawsuit says he “experiences daily knee pain and discomfort which limit [his] activities of daily living and recreation,” affecting his quality of life.
Which Injuries Are Claimed in Exactech Lawsuits?
Lawsuits claim several different injuries that may require revision surgery. All injuries may result from faulty packaging, leading to early failure or other complications.
- Accelerated debris
- Bone loss from osteolysis
- Cracking, grinding, clicking or other noises in the joint
- Inability to bear weight
- Instability
- Joint swelling
- Limited mobility or pain while walking
- Loosening
- New or worsening pain
- Osteolysis
- Polyethylene wear
- Revision surgery because of osteolysis or polyethylene wear
Typically, 95% of knee replacements should last 10 years or more. But some loosened in as little as two or three years, according to Dr. Christopher Hutchins, a Connecticut orthopedic surgeon. Hutchins used Exactech’s Opetrak devices in 350 knee surgeries. He said in a deposition that this was “awfully premature” and “extraordinary,” according to a report by KFF Health News.
Exactech also warned doctors its Connexion GXL hip liner, used in hip replacement surgery, may also experience wear and tear earlier than expected. This can lead to bone tissue loss and require revision surgery — removing and replacing the artificial joint. Exactech did not announce a hip replacement recall for the device but has stopped producing it in the U.S.
Exactech Lawsuit Settlements
No verdicts or settlements have been reached in ongoing Exactech lawsuits. Lawyers are still accepting new clients.
Meanwhile, Exactech has hired Broadspire to help settle claims. However, receiving a settlement from Broadspire only reimburses money you already spent and won’t cover future medical care, lost wages, or provide a free replacement for a failed implant.
Past Exactech Litigation
Exactech faced legal issues in the past for providing faulty knee replacements to VA, Medicare and Medicaid beneficiaries.
The company also paid orthopedic surgeons to use their hip and knee implants and submitted false claims to Medicare. This resulted in a lawsuit by the Department of Justice. Exactech settled the case with the federal government in 2010 for nearly $3 million.
Choosing an Exactech Lawsuit Attorney
Choosing an experienced attorney for an Exactech lawsuit who can fight against medical device companies is important. Look for a national law firm with a track record of winning settlements and jury verdicts.
For example, Drugwatch has partnered with leading national firms with a history of obtaining billions in multidistrict litigation settlements and jury verdicts in medical device cases similar to Exactech lawsuits. The Exactech MDL judge has appointed our legal partners to leadership positions in the litigation.
When choosing an Exactech attorney make sure to ask them about their experience with medical device lawsuits, if they have been successful at trial and if they have successfully obtained settlement for their clients.
What To Do If Your Exactech Replacement Was Recalled
If you had a recalled Exactech implant, contact your doctor to check for early wear or bone loss.
You may file a claim with the company or take legal action. But you should contact an attorney immediately if you choose to sue.
Most law firms offer free case reviews and only charge if they recover compensation for you.
Calling this number connects you with a Drugwatch.com representative. We will direct you to one of our trusted legal partners for a free case review.
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