Joint replacements are meant to reduce patient pain and help them return to living a normal life. In addition to a skilled surgeon, it’s imperative that the joint replacement devices implanted in the patient’s joints are both functioning and safe.
However, Exactech recalled thousands of knee, ankle, and hip replacement prostheses due to a fault with the plastic packaging used to store the polyethylene inserts for those joint replacements. The faulty packaging exposed the polyethylene liners and inserts to become exposed to oxygen in the air. As a result, the joint replacement prosthetic can degrade, causing the replacement device to fail sooner.
Exactech has established a process to help patients file claims and get reimbursed for the costs of the joint replacement device. However, this reimbursement might not cover things like lost wages, pain and suffering, or revision surgery. There are thousands of lawsuits against Exactech filed by plaintiffs who had to undergo additional medical treatment as a result of the failure of their joint replacement device.
Who Is Exactech?
Exactech is a medical device company founded in 1985 by doctors who wanted to help enhance patient experience by bringing their expertise from their time as surgeons. They wanted to use their perspective as surgeons to create a medical device company by surgeons, for surgeons.
What Does Exactech Manufacture?
Exactech manufactures knee, hip, shoulder, foot, and ankle replacement devices and the components that enable them to work. The company also manufactures technology that assists surgeons during the surgery process via computer.
Why Were Exactech’s Knee, Hip, and Ankle Replacements Recalled?
Exactech recalled a number of its knee, hip, and ankle replacements beginning in 2021. These devices were recalled due to faulty packaging that didn’t meet the required specifications. Because of the packaging, polyethylene inserts used in the joint replacement devices were exposed to oxygen, which caused them to degrade and fail early. In 2022, Exactech expanded the list of recalled devices and sent an urgent communication regarding the matter to medical professionals.
The recalled hip replacements were faulty because the metal-on-metal components could release metal debris into the body, which could cause cobalt poisoning, metallosis, and more. These defective hip replacements had to be replaced via revision surgery.
On top of that, the initial list of recalled devices only included specific devices, but the expanded list included all products that had been inserted into the faulty packaging no matter what label the product had or what the shelf life of the product had been.
What Is a Polyethylene Liner?
In the medical field, polyethylene is widely used in implant procedures to replace some bone and joint components. These are typically combined with metal alloys and ceramic materials. These surgeries are often done for replacements of knee, ankle, hip, or other joints. Exactech used such polyethylene liners in its knee and ankle replacement devices. It was this liner that was exposed to the air due to faulty packaging and began to degrade more quickly than it should have.
Which Exactech Products Have Been Recalled?
The Exactech joint replacement products included in the initial recall are the following:
- OPTETRAK® Unicondylar Tibial Components
- OPTETRAK® All-polyethylene CR Tibial Components
- OPTETRAK® All-polyethylene PS Tibial Components
- OPTETRAK® B-Series Ps Tibial Insert
- OPTETRAK® CC Tibial Inserts
- OPTETRAK® CR Tibial Inserts
- OPTETRAK® CR Slope Tibial Inserts
- OPTETRAK® PS Tibial Inserts
- CUSTOM OPTETRAK® Angled PS Insert
- CUSTOM OPTETRAK® CC Tibial Insert
- OPTETRAK® HI-FLEX® PS Tibial Inserts
- OPTETRAK “MOMB” Non-Mod Molded Insert
- OPTETRAK® RBK PS Tibial Components
- OPTETRAK Logic® CR Tibial Inserts
- OPTETRAK Logic® CR Slope Tibial Inserts
- OPTETRAK Logic® CRC Tibial Inserts
- OPTETRAK Logic® PS Tibial Inserts
- OPTETRAK Logic® PSC Tibial Inserts
- OPTETRAK Logic® CC Tibial Inserts
- TRULIANT® CR Tibial Inserts
- TRULIANT® CR Slope Tibial Inserts
- TRULIANT® CRC Tibial Inserts
- TRULIANT® PS Tibial Inserts
- TRULIANT® PSC Tibial Inserts
- VANTAGE® Fixed-Bearing Liner Ankle Component
- Catalog numbers 136-40-XX
- Novation GXL Liner
- +5mm Lateralized, 40mm
- Orthopedic hip implant component
What Is Exactech’s Claims Process?
Exactech offers reimbursements to patients whose joint replacement device has been included in either of the two recalls and has advised surgeons to contact patients whose joint replacements were affected. The company offered two hotlines, one for a recording answering frequently asked questions and the other ((888) 912-0403) to begin the claims process.
Patients wanting to initiate a claim will need the following information:
- Date of the joint replacement surgery
- Name of the surgeon
- Joint replacement device serial number – this should be available in the patient’s medical records, but a claim can be initiated without it so long as the name of the surgeon is provided. Exactech can contact the surgeon for the serial number if necessary.
During that initial phone call, a claim number will be generated that the patient should note down and keep for future reference, as it will be needed during the claims process. Instructions for the next steps in filing the claim will also be provided.
What Costs Will Exactech Cover?
Exactech’s claims process may result in patients receiving compensation for the following:
- Cost of the joint replacement
- Lost wages
- Pain and suffering
- Medical bills
However, some patients have sued Exactech for further compensation because of the additional medical treatment they had to undergo, often including early revision surgery to correct the problem caused by Exactech’s faulty packaging.
Additionally, Exactech’s claims process means that patients have to pay up-front for their medical costs to be reimbursed later, which can be made more difficult if they are unable to work. On top of that, patients would have to pay the additional medical costs with no real guarantee that Exactech would reimburse them for the full amount. Exactech may only be willing to pay proven out-of-pocket costs. Pain and suffering and poorer quality of life are more difficult to quantify and therefore may not be included in the reimbursement from the company.
Why Are Plaintiffs Suing Exactech?
There have been numerous lawsuits filed against Exactech, despite the company recalling the affected devices and offering a process for filing claims for reimbursement. Plaintiffs who filed lawsuits against Exactech sued because they’d had to undergo further medical treatment for complications caused by the degradation of the polyethylene liners. Many of these plaintiffs had to undergo revision surgery to correct the problem. The reimbursement offered to patients by Exactech may not have covered the costs of additional medical treatment, especially surgery, to correct problems caused by faulty packaging.
What Exactech Lawsuit Settlements Have There Been?
In 2010, Exactech settled a lawsuit brought by the Department of Justice. The Department of Justice had sued Exactech because it had paid surgeons to use its products between 2002 and 2008. This ultimately resulted in false claims to Medicare being submitted. Exactech was also sued in 2020 by whistleblowers who accused the company of knowingly providing faulty joint replacements to the VA.
Lawsuits that have come from the Exactech recalls in 2021 and 2022 are still ongoing and therefore don’t have known settlements at this time.
What Exactech Joint Replacement Lawsuits Are There?
The current set of lawsuits against Exactech, brought about by plaintiffs who were directly affected by early joint failures caused by Exactech’s usage of faulty packaging, number in the thousands. This batch of lawsuits has only been filed recently after Exactech’s recalls were announced in 2021 and 2022. Therefore, it’s too early to know what settlements may be possible. However, Exactech recalled hundreds of thousands of devices, meaning that there are hundreds of thousands of patients who could have been negatively impacted by the company’s faulty packaging.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.