Lawsuit Claims Cartiva SCI Failure Caused by Defective Design of Big Toe Implant

Cartiva is being accused of inflating the implant’s success rate and hiding reports of device failure due to shrinkage.

A North Carolina woman indicates in a recently filed product liability lawsuit that she has lost significant mobility after her Cartiva Synthetic Cartilage Implant (SCI) shifted out of position, requiring removal and fusion of her big toe.

The complaint (PDF) was brought earlier this month in the U.S. District Court for the Eastern District of North Carolina by Judy Kiel, alleging that Cartiva, Inc. designed and manufactured a defective big toe implant, which was subsequently recalled from the market amid similar reports of problems experienced by patients nationwide.

The Cartiva SCI is a molded cylindrical device that was introduced in 2016, which is made from polyvinyl alcohol-based (PVA) hydrogel. The manufacturer promoted the implant as an innovative alternative for patients with hallux limitus or hallux rigidus, which are forms of degenerative arthritis affecting the big toe joint.

However, the FDA announced a nationwide Cartiva SCI recall in October 2024, after the company admitted it was seeing “higher-than-expected” failure rates. When the implant fails, not only does it require revision surgery, but often also requires the big toe to be fused into immobility.

Kiel is one of a growing number of patients who are now pursuing Cartiva SCI lawsuits, indicating that implant failures left them with severe pain, reduced range of motion and other complications. Each complaint makes similar claims, that Cartiva failed to properly design and test the implant before putting it into the stream of commerce.

According to her lawsuit, Kiel received her Cartiva SCI implant in her right big toe December 2022. However, rather than helping reduce her symptoms, she began to develop persistent pain and stiffness in her entire foot, along with a limited range of motion, which is the exact opposite of what the implant was supposed to achieve.

Earlier this year, Kiel’s doctor determined that the implant had subsided, or shrunk, two millimeters out of position. The complaint indicates that many medical experts warn this shrinkage is a sign of pending implant failure.  

In May 2025, Kiel’s doctor performed revision surgery to remove the failed Cartiva SCI implant, and then permanently fused her big toe into place.

The lawsuit accuses Cartiva of inflating the implant’s success rate even as it received numerous complaints about the device’s failure.

“These claimed success rates, however, do not exist in clinical practice. Actual patient results have reported failure rates of 64% as opposed to the 13.5% failure rate Defendant reported to the FDA.”

— Judy Kiel v. Cartiva, Inc.

Kiel’s lawsuit presents claims of strict products liability design, manufacture and failure to warn, Negligence – design, manufacture, misbranded and improper transfer of 510(k) without FDA approval, misbranded and adulterated device, breach of express warranty, and violations of state and common law product liability. She seeks both compensatory and punitive damages.

Cartiva SCI Lawsuit Settlement Negotiations

While no global Cartiva settlement agreement has been announced to resolve all claims brought by individuals who experienced problems with the toe implant, there has been growing speculation that the manufacturer is entering into confidential Cartiva lawsuit settlement agreements or tolling arrangements with certain law firms.

The speculation comes after several recently filed lawsuits, all following the October 2024 recall, were quietly and voluntarily dismissed.

In the meantime, other individual claims have been proceeding through formal discovery and pretrial proceedings, with trial dates set in 2026 in a few of the pending cases.

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