With the Exactech multidistrict litigation (MDL) expected to go to trial sometime next year, lawyers on both sides of the litigation are actively involved in discovery, motions practice, and settlement negotiation preparations. While settlement in the Exactech lawsuit appears likely, the outcome is still far from certain, and the lawyers involved are still operating under the assumption that going to trial may be necessary. 

While the Exactech MDL shares many similarities with other large-scale product-related cases, there are several unique aspects to the case as well—including the potential value of individual plaintiffs’ claims. This article provides a comprehensive overview of what patients and their families need to know. 

“The pending multidistrict litigation against Exactech involves multiple types of injuries and medical complications linked to apparent defects in Exactech’s ankle, hip, knee, and shoulder implant devices and their packaging. While thousands of plaintiffs have joined the litigation, Exactech has recalled hundreds of thousands of its devices—which means that numerous patients and families have yet to assert their legal rights.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C. 

Although Exactech is currently fighting plaintiffs’ claims in the MDL, it has acknowledged serious safety issues associated with its implantable medical devices in the past. While this will play a key role in the parties’ settlement negotiations, there are no guarantees as to the outcomes that plaintiffs will be able to achieve. As a result, experienced legal representation is critical, and anyone who believes they may have a claim against Exactech should consult with a lawyer who is actively handling these claims as soon as possible. 

What is the Crux of the Exactech MDL? 

The Exactech MDL focuses on plaintiffs’ allegations that the Exactech knee, ankle, hip and shoulder replacement devices have caused various forms of harm due to the devices’ degradation in their bodies. The company has acknowledged that issues with these devices’ packaging allowed them to oxidize, which causes the materials in the devices to break down over time. This degradation can lead not only to the failure of patients’ joint replacements, but also to bone damage, soft tissue damage, infections, and other health issues that can have serious—and permanent—complications, including the need to undergo corrective revision surgery. 

When Were the Issues with Exactech’s Implantable Medical Devices First Discovered? 

The issues with the Exactech implants were first discovered in June 2021. This is when they issued the first Exactech implant recall for its AcuMatch, MCS, and Novation hip implant devices. At the time, Exactech acknowledged that issues with the Exactech hip devices presented risks for “excessive and premature wear,” which led the U.S. Food and Drug Administration (FDA) to classify the recall in Class II. This reflects the FDA’s determination that: 

“[U]se of, or exposure to, [these devices] may cause temporary or medically reversible adverse health consequences or . . . the probability of serious adverse health consequences is remote.”

However, in the years since the original Exactech recall, several patients have filed lawsuits alleging that the degradation and failure of their recalled Exactech implants have caused permanent complications. This is a major factor contributing to the high anticipated average settlement value in the Exactech MDL (discussed in greater detail below).

In the years since the original Exactech medical device recall, the company has also expanded this recall and issued several additional recalls for its other implantable devices. Currently, the Exactech devices that are subject to recalls—and that are the subject of the Exactech MDL—include ankle, hip, knee, and shoulder implants sold under the following brands: AcuMatch, Connexion, MCS, Novation, Optetrak, Optetrak Logic, Truliant, and Vantage. 

Are All of Exactech’s Implantable Medical Devices Subject to Recalls? 

Although Exactech has issued multiple recalls for its implantable medical devices, not all of the company’s devices are subject to active recalls. Crucially, however, a recall is not necessary for patients and families to pursue legal action. While the lawsuits filed in the Exactech MDL to date generally involve recalled devices, anyone who believes they may have a claim against Exactech related to an implant failure should consult with an attorney about their legal rights and whether to file an Exactech lawsuit. 

What is an Urgent Medical Device Correction Notice?

Along with issuing multiple recalls, Exactech has also issued multiple Urgent Medical Device Correction notices related to the recalled Exactech knee replacement systems, ankle replacements, hip replacement devices and shoulder devices. As their name suggests, these notices warn healthcare providers and patients of urgent health risks associated with the subject devices. Through these notices, Exactech has advised healthcare providers not to implant many of its devices—which sends a clear signal that the company is fully aware of the significant health risks that these implantable medical devices present. 

What is the FDA Doing About the Safety Risks Associated with Exactech’s Recalled Devices? 

The FDA has also issued multiple warnings about the health risks associated with Exactech’s ankle, hip, knee, and shoulder replacement devices. This includes an omnibus Safety Communication that the agency issued in March 2023. In that Safety Communication, the FDA writes: 

“The [FDA] is reminding patients and health care providers about Exactech joint replacement devices manufactured by Exactech between 2004 and August 2021, and recalled in 2021 and 2022. Many Exactech joint replacement devices (including knees, ankles, and hips) were packaged in defective packaging bags . . . . [that] were missing one of the oxygen barrier layers that protect devices from oxidation . . . . Oxidation can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery. Some of the recalled devices are associated with increased risk of revision surgeries and bone loss related to excessive device wear/failure.”

The FDA goes on to specifically recommend against healthcare providers implanting any recalled Exactech knee replacement system or its ankle, hip devices, and it advises patients to contact their healthcare providers about treatment options if they have, “any new or worsening pain or swelling, inability to bear weight, grinding or other noise, or weakness around [an] implanted device.”

What Are Plaintiffs Alleging in the Exactech MDL? 

Plaintiffs in the Exactech litigation are alleging that flaws in the manufacturing processes, procedures, and safeguards of the global medical device company caused the company to sell dangerous and defective joint replacement devices. While plaintiffs are pursuing other causes of action as well, these product defect claims are at the heart of the matter. Since product defect claims subject manufacturers to strict liability when proven, proof of negligence regarding the Exactech device is not required for the plaintiffs to succeed in the Exactech recall lawsuits. Instead, if plaintiffs can prove that Exactech’s devices are defective—and there is strong evidence (including Exactech’s own statements) indicating that they are—this is enough to establish their right to just compensation. 

What Damages Are Plaintiffs Seeking in the Exactech MDL? 

In the Exactech implant recall MDL, plaintiffs are seeking damages for all of the costs—past, present, and future—resulting from the degradation and/or failure of their Exactech knee implants, ankle implants, and hip or shoulder implants. This includes not only their medical costs (including the cost of revision surgery in many cases), but also other out-of-pocket expenses and non-financial losses. As noted above, while some patients who received defective medical device implants will only experience short-term costs and effects, Exactech’s devices can also cause permanent injuries and complications. While it is important for all plaintiffs to work with experienced Exactech lawyers to ensure that they are seeking the full compensation to which they are legally entitled, this takes on heightened importance for those who will be dealing with the effects of their devices’ defects for the rest of their lives. 

What Are the Anticipated Settlement Amounts in the Exactech MDL? 

Currently, the anticipated average settlement amount in the Exactech MDL is somewhere in the range of $100,000 to $300,000. However, the value of individual plaintiffs’ claims varies widely—with many claims both below and well above this range. Again, however, it is important to stress that a settlement is not guaranteed, and it will be up to plaintiffs to work closely with their attorneys to maximize their chances of recovering full compensation. 

Do Patients Still Have Time to File Exactech Lawsuits? 

Yes, patients generally still have time to file Exactech lawsuits—though time is running out for some claims. With this in mind, our firm is strongly recommending that anyone who thinks they may qualify for an Exactech knee replacement lawsuit or other Exactech claim consult with an attorney as soon as possible. The filing deadline to file is based, in part, on when patients received their Exactech joint replacement implants; and, once the deadline for a patient’s claim passes, the patient (and the patient’s family) will no longer be able to assert their legal rights. 

When is the Exactech MDL Expected to Go to Trial? 

Currently, the Exactech MDL is expected to go to trial sometime in the summer or fall of 2025. However, this could change, and some of the pre-trial deadlines in the litigation have been pushed back at least once already. We anticipate that the parties will enter into settlement negotiations well before the trial date arrives; and, while there are no guarantees, we believe there is a strong chance that the Exactech MDL will be resolved via pre-trial settlement.