Cartiva Problems Suppressed By Manufacturer Before Toe Implant Recall: Lawsuit

FDA determined that as few as one-fifth of Cartiva toe implants may have successfully reduced pain, suggesting many individuals did not receive the intended benefits.

A Kentucky woman has filed a product liability lawsuit alleging her Cartiva synthetic cartilage implant (SCI) was marketed as being a permanent device, yet it failed approximately one year after being recalled.

The complaint (PDF) was brought by Sandra K. Downey in the U.S. District Court for the Western District of Kentucky on September 23, naming Cartiva Inc., Wright Medical Technology Inc. and Stryker B.V. as the defendants.

Downey claims the defendants waited months to warn doctors and patients before officially pulling the Cartiva SCI from the market, suggesting they knew about alleged design defects while she was preparing to undergo surgery.

Cartiva Implant Problems

The Cartiva SCI is a molded cylindrical implant placed in the big toe of patients suffering from degenerative and post-traumatic arthritis known as hallux limitus and hallux rigidus. The typical treatment for the condition is often fusion of the big toe, which permanently lessens the individual’s mobility and can profoundly affect those with an active life.

Constructed from polyvinyl alcohol-based gel and first approved in 2016, the Cartiva SCI was promoted as an alternative to big toe fusion. According to Downey, Cartiva Inc. marketed the implant as providing 97% pain reduction and an 87% success rate, telling doctors it would last a “lifetime.”

When the Cartiva recall was announced in October 2024, the U.S. Food and Drug Administration (FDA) estimated the actual success rates only ranged from 21% to 46%, meaning even the agency’s most generous estimate indicates most Cartiva implants failed.

A series of Cartiva toe lawsuits filed nationwide allege the manufacturers knew the design was dangerous, defective and prone to failures that often led to patients needing the implant to be surgically removed. These complications also resulted in most individuals requiring the big toe fusion procedure they sought to avoid in the first place.

Cartiva Implant Failure Allegations

Downey’s lawsuit was filed almost exactly two years after she first underwent a procedure to receive the Cartiva SCI implant in her right big toe. She began developing chronic pain after the surgery.

On October 30, 2024, all Cartiva implants were recalled due to their high failure rate. Like many recipients, Downey’s implant also allegedly failed, with the device being removed in October 2025 due to persistent pain. Her big toe was fused into place as a result.

Following the experience, Downey indicates she continues to suffer chronic pain and stiffness in her right foot, as well as limited range of motion.

Downey says her injuries, permanent mobility loss and medical expenses could have been avoided if the manufacturer had warned the medical community that it already knew about the failure rates. Instead, the lawsuit indicates the company waited, at the expense of Downey and others.

“Defendants had already made the decision to issue the recall prior to Plaintiff’s implant surgery, and already had conducted a Health Hazard Evaluation and/or Health Risk Assessment which showed the Cartiva’s high failure rate. Defendants had the ability to disclose this information to Plaintiff and her medical providers, but they did not do so.”

– Sandra K. Downey v. Cartiva Inc. et al.

The lawsuit raises allegations of failure to warn, misbranding and adulteration, negligent training, product liability and negligence for class II/class III Devices and breach of warranty. It seeks both compensatory and punitive damages.

Cartiva Lawsuits

All Cartiva implant lawsuits were consolidated this summer in the Eastern District of Arkansas before U.S. District Judge Kristine G. Baker for coordinated discovery and pretrial proceedings in what is known as a multidistrict litigation (MDL).

The MDL is just getting underway, with the judge issuing an initial management order on August 31, which included the appointment of about a dozen plaintiffs’ attorneys to leadership positions in the litigation.

The judge has called for a continuing series of status conferences to keep all involved in the case up to date. The next status conference is scheduled for October 8, 2026.

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