Lawsuit Claims Cartiva Implant Caused Bone Loss and Nerve Damage in Big Toe

Researchers warned that the toe implant failure rate was 64% as early as 2020, yet the manufacturer did not issue a Cartiva recall until October 2024.

A Pennsylvania woman has filed a product liability lawsuit, alleging it took years for her to discover that her Cartiva toe implant had failed due to design defects that the manufacturer concealed.

Kelly M. Peachey filed the complaint (PDF) against Cartiva Inc. in the United States District Court for the Western District of Pennsylvania on August 8, after multiple surgeries ultimately led to her big toe being fused and losing mobility, the exact opposite of the implant’s intended purpose.

The Cartiva SCI (synthetic cartilage implant) is a molded cylindrical implant constructed of polyvinyl alcohol-based hydrogel (PVA), which the manufacturer promoted as a revolutionary alternative for individuals suffering from hallux limitus or hallux rigidus.

However, over the last several months, more and more plaintiffs like Peachey have filed Cartiva implant lawsuits after the devices were linked to high failure rates, leading to severe pain, implant loosening and other complications. Those high failure rates eventually led to a Cartiva recall issued by the manufacturer in October 2024.

Peachey’s lawsuit indicates she received her Cartiva right big toe implant in December 2019. However, by August 2021, doctors informed her that the implant had failed.

The next month, Peachey underwent another surgery to remove the Cartiva and fuse her big toe. However, she again required surgery in March 2023, due to a screw fracture and a failure of the previous toe fusion.

“The Cartiva implant surgical procedure was not effective at alleviating pain or restoring range of motion… In addition to a loss of range of motion of the great toe, Plaintiff experienced loss of mobility, nerve damage and debilitating pain of the right great toe, along with constant irritation and discomfort in the location of the artificial Cartiva device.”

–Kelly M. Peachey v. Cartiva, Inc.

The complaint indicates that Peachey did not learn the problems were widespread or potentially the result of defective design until the recall in October 2024. This was because Cartiva purposefully suppressed adverse data from U.S. Food and Drug Administration investigators, the lawsuit argues.

Peachey and other plaintiffs indicate that a 2020 study revealed that the Cartiva toe implant had a 64% failure rate, as opposed to the 13.5% failure rate previously claimed by the manufacturer, which was exactly what was required for approval by the FDA.

According to the lawsuit, there are 144 adverse event reports to date filed with the FDA, with the majority of complaints involving implant loosening or failure.

As a result, Peachey claims that Cartiva should have known their implant needed to be recalled long before it was in October 2024, which would have saved her from the injuries she alleges are a direct result of the product’s malfunction.

The lawsuit presents claims of strict product liability design, manufacture and failure to warn, negligence, design manufacturer, misbranded and improper transfer of 510k approval, misbranded and adulterated device, breach of warranty, and state and common law claims of product liability and negligence. It seeks both compensatory and punitive damages for Peachey.

Cartiva Lawsuit Settlement Negotiations

The complaint comes after several similar claims were quietly and voluntarily dismissed, leading to speculation that a global settlement agreement may be in the works, but that has not yet been confirmed.

Peachey indicates she has entered into a tolling agreement with the manufacturer, meaning Cartiva does not plan to claim she waited too long to file a complaint.

While no formal Cartiva settlement program has been announced, the pattern of case activity suggests that resolution talks may already be underway, potentially signaling a shift in how the manufacturer intends to manage the growing litigation.

In the meantime, the first Cartiva lawsuit trial is scheduled to begin on October 28. The second Cartiva SCI trial will be held in February 2026.

Although the outcomes of these trials will be closely watched by those involved in Cartiva proceedings, the results will not be binding on any other Cartiva SCI lawsuits.

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