Exactech Lawsuit
An Exactech lawsuit is a claim requesting compensation for injuries related to Exactech hip, knee and ankle replacements. Exactech issued recalls in 2021 and 2022 for hip, knee and ankle replacements packaged in defective bags. In 2024, they expanded the recall to include shoulder replacement devices. These devices all have the potential for early failure.
Latest Exactech Lawsuit Updates
As of December 2024, there were 1,839 lawsuits pending in multidistrict litigation before the U.S. District Court, Eastern District of New York. So far, there have been no trials or approved settlements in MDL 3044.
Updates in Exactech Lawsuits
- October 2024: Exactech has filed for bankruptcy in response to the mounting litigation. Pending lawsuits against Exactech have been paused for now as a result of the bankruptcy filing. Earlier this month, the two bellwether trials in the MDL received new dates. The Tarloff trial was set for Sep. 29, 2025 with the Larson trial set to start on Nov. 10, 2025. The scheduling of future bellwethers beyond those two was also postponed.
- August 2024: There has been a moderate delay to the start of the first two bellwether trials in the MDL following ongoing discovery disputes. Gayle Tarloff’s trial is now set to begin on July 6, 2025, with Geraldine Larson’s trial moving to Sep. 29, 2025. The trials had previously been set for June and August of that year.
- April 2024: Courts set the initial bellwether trial date for June 2025 to try plaintiff Gayle Tarloff’s case.
- 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 assigned to U.S. District Judge Nicholas G. Garaufis.
- March 2023: According to an order from Magistrate Judge Marcia M. Henry, all plaintiffs in the MDL must complete Plaintiff Facts Sheets before June 6, 2023.
- January 2023: Magistrate Judge Henry signed a protective order that counsel for both plaintiffs and defendants signed that spelled out the handling of confidential documents that will be part of discovery in the litigation.
- October 2022: The Panel on Multidistrict Litigation approved the request to consolidate cases from around the country and transfer them to the Eastern District of New York with Judge Garaufis overseeing coordinated proceedings.
Plaintiffs in Exactech lawsuit are seeking compensation for injuries related to joint replacement devices. In March 2023, the FDA reminded medical providers and the public about the defective packaging for many of Exactech’s joint replacement devices manufactured between 2004 and August 2021. Defective packaging could cause early degradation of devices and lead to revision surgery.
What Are Exactech Lawsuits?
Exactech lawsuits are product liability claims asking that Exactech pay compensation to those injured by the company’s defective knee, ankle and hip implants. In 2021 and 2022, Exactech recalled its Ultra-High Molecular Weight Polyethylene Knee and Ankle Polyethylene Inserts manufactured between 2004 and August 2021 because product packaging was not up to specifications. Truliant knee, Optetrak knee and Vantage ankle devices used these inserts.
“The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation, a chemical reaction with oxygen that can degrade plastics over time. Oxidation can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery,” according to the U.S. Food and Drug Administration’s March 23, 2023, safety communication.
In June 2021, Exactech recalled some GXL liners used in MCS, Acumatch and Novation hip implants because of premature and excessive wear. However, the company didn’t provide a reason for the wear problems. In August 2022, the company expanded its original recall to include all devices with plastic components packaged in defective bags.
By March 2024, Exactech voluntarily recalled its Equinoxe Shoulder System implants for the same packaging defects.
Exactech Lawsuit Settlements
Some lawyers estimate a potential Exactech lawsuit settlement to be between $100,000 to $300,000. This is a projection based on knee replacement settlements from past lawsuits. A claimant could receive a smaller or larger settlement depending on the injuries claimed.
So far, there have been no court-approved Exactech lawsuit settlements. Typically, bellwether trials determine potential settlement amounts. The first bellwether trial is scheduled for June 2025.
Why Are People Filing Exactech Replacement Lawsuits?
People are filing Exactech lawsuits to get compensation for damages incurred because of potentially defective Exactech hip, knee and ankle implants. They claim Exactech knew these products were faulty but the company still sold them, making it guilty of negligence, among other claims.
- Breach of warranty
- Failure to warn
- Fraud
- Negligence
- Strict product liability
At least 143,484 potentially defective inserts were implanted in the U.S., according to Exactech’s April 2022 Urgent Medical Device Correction letter. These devices could have put tens of thousands of Americans at risk of early failure after Exactech knee or ankle replacements.
Injuries Claimed in Exactech Lawsuits
Those who received a recalled Exactech implant could face many painful complications. When devices fail early, symptoms may include pain, bone loss and problems with mobility. Sometimes, the only way to correct these issues is through revision surgery.
- Bone loss
- Component fracture
- Device failure
- Difficulty walking
- Dislocations
- Early and excessive device wear
- Inability to bear weight
- Instability
- New or worsening pain
- Noises such as clicking, grinding or popping
- Revision surgery
- Swelling
“Recipients of the Optetrak knee implants have required painful revision surgeries well before the estimated life expectancy of the devices, and at a much higher rate than should reasonably be expected for devices of this kind,” according to one Exactech lawsuit filed by Joseph D. Sexton and his wife, Corrine.
Who Can File an Exactech Lawsuit?
If you received a recalled Exactech knee, hip or ankle implant and had to have surgery or your health care provider advised you to have surgery, you may qualify to file an Exactech lawsuit. Check your medical records or speak with your orthopedic surgeon to verify the implant you received.
If you aren’t sure what brand of implant you have, you can request the assistance of a product liability lawyer. Lawsuits include devices manufactured between 2004 and August 2021.
- Acumatch Hip with Connexion GXL liner
- MCS Hip with Connexion GXL liner
- Novation Hip with Connexion GXL liner
- Optetrak Knee: 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 Knee: CR Tibial Inserts, CR Slope Tibial Inserts, CRC Tibial Inserts, PS Tibial Inserts, PSC Tibial Inserts, CC Tibial Inserts
- Truliant Knee: CR Tibial Inserts, CR Slope Tibial Inserts, CRC Tibial Inserts, PS Tibial Inserts, PSC Tibial Inserts
- Vantage Ankle: Fixed-Bearing Liner Component
- Pain
- Stiffness
- Limited mobility
- Radiographic evidence of osteolysis
- Loosening because of osteolysis
Exactech advised doctors to contact patients implanted with recalled devices. But if you haven’t received a call from your doctor, contact their office to schedule a follow-up appointment.
What Should You Do if You Were Injured by an Exactech Replacement?
If you suffered any complications or injuries from an Exactech replacement, schedule an evaluation with your doctor. If you received a recalled implant, it’s a good idea to contact your doctor regardless of any current problems. Some people may not have symptoms even if the device is degrading prematurely.
Your doctor may schedule surgery if the implant is causing problems or has failed. However, the FDA doesn’t recommend surgery for people who aren’t having issues with their implants.
Exactech offers direct compensation to those affected by recalled implants, but signing any paperwork with Exactech may prevent you from filing a lawsuit against them. Before contacting Exactech, speak to a lawyer about your legal rights. Lawyers offer free case evaluations without obligation for people injured by Exactech knee, hip or ankle implants.
13 Cited Research Articles
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- United States Judicial Panel on Multidistrict Litigation. (2024, December 2). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-December-2-2024.pdf
- Exactech. (2024, October 29). Exactech Reaches Agreement with Investor Group to Build Foundation for Future Growth. Retrieved from https://www.prnewswire.com/news-releases/exactech-reaches-agreement-with-investor-group-to-build-foundation-for-future-growth-302289670.html
- U.S. District Court for the Eastern District of New York. (2024, August 16). Re: MDL No. 3044, In re: Exactech Polyethylene Orthopedic Products Liability Litigation, 1:22-md-03044-NGG-MMH – Pretrial Schedules for Tarloff and Larson Bellwethers. Retrieved from https://ecf.nyed.uscourts.gov/doc1/123121604977
- U.S. Food and Drug Administration. (2024, April 19). Risks with Exactech Equinoxe Shoulder System with Defective Packaging. Retrieved from https://www.fda.gov/medical-devices/safety-communications/risks-exactech-equinoxe-shoulder-system-defective-packaging-fda-safety-communication
- U.S. Food and Drug Administration. (2023, March 23). Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/risks-exactech-joint-replacement-devices-defective-packaging-fda-safety-communication
- United States Judicial Panel on Multidistrict Litigation. (2023, March). Plaintiff Facts Sheets Order. Retrieved from https://ecf.jpml.uscourts.gov/cgi-bin/show_temp.pl?file=1140914-0--41477.pdf&type=application/pdf
- Sexton v. Exactech Inc. (2022, November 11). Complaint and Jury Demand. Retrieved from https://www.aboutlawsuits.com/wp-content/uploads/2022-11-11-exactech-sexton-complaint.pdf
- United States Judicial Panel on Multidistrict Litigation. (2022, October 7). MDL Transfer Order. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3044-Initial-Transfer-Order-9-22.pdf
- Exactech. (2022, February 7). Exactech Ankle Patient Letter. Retrieved from https://www.exac.com/product/exactech-ankle-patient-letter/
- Exactech. (2022, February 7). US Recall Information, Knee/Ankle. Retrieved from https://www.exac.com/medical-professionals/recall-information/
- Exactech. (2022, February 7). Exactech DHCP Letter. Retrieved from https://www.exac.com/product/exactech-dhcp-letter/
- Exactech. (2022, February 7). Frequently Asked Questions: Knee and Ankle Recall. Retrieved from https://www.exac.com/wp-content/uploads/2022/02/Exactech-Knee-and-Ankle-FAQ.02.07.2022_Letterhead.pdf
- Exactech. (2021, June 24). FAQ – GXL Liners for Novation, Acumatch and MCS Systems. Retrieved from https://www.exac.com/wp-content/uploads/2021/06/Frequently-Asked-Questions-FAQs-for-US-Agents-Surgeons_FINAL_GXL.pdf
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