The recently revised pre-trial schedule in the multidistrict litigation (MDL) against Exactech gives new plaintiffs more time to join the litigation before it heads to trial next year. That is, of course, assuming that the litigation doesn’t settle—which appears to be a strong possibility at this stage. By the time the trial date arrives (if it arrives), it will have been more than five years since the issues with Exactech’s medical implant devices were first uncovered.

In this article, we’re looking at plaintiffs’ claims in the Exactech multidistrict litigation. The litigation is extremely broad, covering various injuries and complications allegedly resulting from multiple defective Exactech medical implant devices. Multiple Exactech knee replacement system recalls are underway, and the U.S. Food and Drug Administration (FDA) has issued multiple warnings and advisories related to Exactech’s recalled devices.

“The Exactech multidistrict litigation is somewhat unique in that it involves multiple defective products that suffer from related, though not necessarily identical, issues. In light of Exactech’s recalls and Urgent Medical Device Correction notices, settlement appears likely, but negotiating a settlement that provides adequate compensation to the plaintiffs—whose injuries and complications vary widely—will take some time and require extremely careful consideration.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

At its core, the Exactech MDL is a defective product case. However, due to the multiple alleged defects and their varied risks for patients who received dangerous Exactech medical device implants, the Exactech MDL also presents some unique considerations for both prospective and current plaintiffs. Here is an overview of some key considerations for current plaintiffs who may be hoping for a settlement and for prospective plaintiffs who have questions about joining the Exactech MDL:

Exactech’s Recalled Medical Implant Devices

The Exactech MDL involves multiple models of the company’s ankle, knee, and hip medical implant devices. Exactech issued the first of several recalls for these devices in June 2021. The June 2021 recall was specific to the company’s AcuMatch, Novation, and MCS hip replacement devices, which contained a GXL-branded liner that the company determined presented a risk for “excessive and premature wear.”

But this was just the start.

Four months later, in October 2021, Exactech recalled its Logic, Optetrak, and Truliant Exactech knee replacement systems and its Vantage ankle replacement devices due to concerns with their packaging. It then expanded this recall in February 2022, when the FDA advised that “around 80% of the knee and ankle replacement devices manufactured since 2004 were packaged in defective bags.” In April 2022, Exactech issued an Urgent Medical Device Correction notice stating that healthcare providers should not implant knee and ankle replacement devices covered under the recall.

Due to additional packaging concerns, Exactech expanded its hip replacement device recall in August 2022. It also issued a recall for its shoulder replacement device systems in June 2023 due to concerns about a tool included with the systems for use during the surgical implant process. However, despite the FDA’s urging, Exactech refused to issue a packaging-related recall for its shoulder replacement device systems in 2024.

Today, hundreds of thousands of Exactech’s devices—many of which have been implanted in patients—are subject to recalls due to significant safety concerns. These same devices are the subject of the Exactech multidistrict litigation. While thousands of patients have filed Exactech lawsuits against the company, it is widely recognized that there are far more prospective plaintiffs out there, including many who have experienced life-altering injuries and complications.

Injuries and Complications Linked to Dangerous Exactech Implants

The issues with Exactech’s recalled medical implant devices and their packaging present several risks for the patients who have had these devices implanted in their bodies. While patients’ specific risks vary case-by-case, some of the primary concerns raised to date in the Exactech recall lawsuits include:

• Catastrophic Failure of the Implanted Medical Device – The packaging and other issues identified with Exactech’s ankle, knee, hip, and shoulder implant devices can cause these devices to degrade inside patients’ bodies. In some cases, this degradation has led to total device failure. The catastrophic failure of Exactech joint replacement devices presents numerous risks for patients—from risks of bone trauma and soft tissue damage to risks of infections.
• Chronic Pain, Inflammation, and Physical Limitations – Even when recalled, Exactech implants do not fail; they can still cause chronic pain, inflammation, and physical limitations. While these complications primarily affect the area surrounding the joint where the device has been implanted, they can sometimes lead to broader health and safety concerns.
• Post-Operative Fluid Collection – The failure of an Exactech implantable medical device can also result in post-operative fluid collection (POFC). While POFC is a relatively benign condition in many cases, “prompt identification and management are paramount [when POFC occurs] adjacent to a joint arthroplasty because of the increased the risk of developing a periprosthetic joint infection.”
• Necrosis – Necrosis is characterized by the death of all or substantially all of the cells within an organ or tissue. Its effects are permanent and can have various lifelong effects depending on the specific organ or tissue affected. In some cases, the breakdown of Exactech’s recalled medical devices has been identified as the cause of patients’ necrosis.
• Osteolysis – Osteolysis is a degenerative condition that causes degeneration of the affected bone (or bones). It can also be caused by the degradation of a recalled Exactech ankle, hip, knee, or shoulder implant device.

For many patients, these injuries and complications (or others) have led to the need to undergo corrective revision surgery. This involves removing the recalled Exactech knee device and replacing it with a new implant. Along with joint replacement surgery, these patients will often need other forms of invasive treatment to remedy (or mitigate) the effects of their Exactech device’s failure.

Exactech’s Strict Liability for Its Defective Products

While the plaintiffs in the Exactech implant recall MDL are pursuing various claims against Exactech, the crux of the Exactech litigation is the plaintiffs’ allegations that the company sold defective medical implant devices. Companies are legally obligated to ensure that the products they design, manufacture, and sell are safe for their intended use. They are subject to strict liability when they fail to meet this obligation.

Although plaintiffs in the Exactech MDL may have strong claims for negligence, breach of warranty, statutory consumer protection violations, and other causes of action, the bar to pursuing a strict liability claim is comparatively low—since proof of the defect is, in and of itself, sufficient to establish the cause of action. This is especially true when, as in the Exactech MDL, the defendant has acknowledged serious product safety concerns.

Establishing strict liability for a product defect is far from easy. With Exactech’s substantial liability in the MDL, the company and its insurers will undoubtedly carefully examine all potential defenses and loss mitigation strategies. As a result, plaintiffs in the MDL will need to rely on their counsel to assert their claims effectively and conduct settlement negotiations on their behalf.

Potential Damages and Settlement Amounts in the Exactech MDL

What is at stake in the Exactech MDL? The short answer is “a lot.” With thousands of claims pending, Exactech and its insurers easily face hundreds of millions of dollars in exposure, if not more. Current estimates put the average plaintiff’s settlement in the range of $100,000 to $300,000, though this is a very generalized range. Many plaintiffs will be entitled to far more—and, again, it will be up to their counsel to ensure that they receive the full compensation they deserve.

What Potential Plaintiffs Need to Know About Filing an Exactech Lawsuit

With all of this in mind, what do potential plaintiffs need to know about filing an Exactech knee replacement lawsuit? Here are some key considerations for recipients of Exactech ankle, hip, knee, and shoulder replacement devices who have not yet joined the MDL:

• Time is of the Essence – While the trial in the Exactech MDL may still be more than a year away, statutes of limitations and other considerations make it important for all potential plaintiffs to consult with an attorney promptly.
• Numerous Exactech Medical Implant Devices Are Involved – In the MDL, Exactech is facing claims related to its AcuMatch, Connexion, MCS, Novation, Optetrak, Truliant, and Vantage medical implant devices, among others.
• Exactech has Acknowledged Safety Risks with Its Recalled Devices – In recalling its devices and issuing Urgent Medical Device Correction notices, Exactech has acknowledged that its ankle, hip, knee, and shoulder replacement devices present risks for patients
• Plaintiffs May Be Entitled to Substantial Damages – Due to the potential for Exactech’s recalled devices to cause substantial harm, many plaintiffs have claims for substantial damages—including both financial and non-financial losses.
• There are No Guarantees – Despite Exactech’s acknowledgements and many pending claims, there are no guarantees. As a result, experienced legal representation is critical.