Cartiva Failure Lawsuit Alleges Implant Caused Instability, Falls and Need for Fusion Surgery

NCAA official says she can no longer do her job after her Cartiva implant failed, requiring her big toe to be permanently fused in place.

An Idaho woman has filed a product liability lawsuit after the alleged failure of her Cartiva toe implant led to the need for revision surgery to fuse her big toe in place.

The complaint (PDF) was brought by Lisa Paull on May 7 in the U.S. District Court for the District of Idaho. It names Cartiva Inc., Wright Medical Group N.V. and Stryker B.V. as defendants.

Paull claims that her Cartiva toe implant was defectively designed, resulting in a failure that caused bone loss and cyst formation, and left her unable to receive a replacement implant.

Cartiva Toe Implant Risks

The Cartiva synthetic cartilage implant (SCI) was designed for patients suffering from hallux limitus or hallux rigidus, both forms of degenerative arthritis in the big toe. Made from polyvinyl alcohol-based gel, the implant was supposed to provide an alternative to having the big toe permanently fused in place.

After increasing reports of complications and a much higher failure rate than the manufacturers originally claimed, the U.S. Food and Drug Administration (FDA) announced a Cartiva implant recall in October 2024. While the agency approved the Cartiva in 2016 based on clinical trials showing an 87% success rate, real-world data revealed that the actual success rate was only somewhere between 21% and 46%.

The recall and revised failure rates have led to an influx of Cartiva failure lawsuits filed by recipients of devices who say they suffered serious complications, including severe toe pain, loosening, fractures and other issues. Often, these complications necessitate surgery to fuse the big toe, resulting in a loss of mobility.

Cartiva Toe Implant Failure Allegations

According to Paull’s lawsuit, she was implanted with a Cartiva SCI toe in November 2020 after the NCAA official and personal trainer began experiencing increasing pain in her big toe. She and her doctor chose the Cartiva implant due to the claims that it would prevent the mobility problems caused by big toe fusion.

However, Paull indicates that while she had a little flexibility, it was not enough for her to continue activities that required her to be flexible and on her toes. Additionally, she began having chronic instability problems in her right big toe, which received the implant, causing her to suffer multiple falls, resulting in injuries to her ribs and tailbone.

The lawsuit also notes that Paull began suffering from right knee pain due to the change in her gait caused by the Cartiva SCI. A doctor attempted to correct the problem with a soft brace.

“This attempt to fix the problem failed. Her toe felt increasingly unstable and by December 2025, a doctor informed Lisa that her body had rejected the implant, that cysts had developed around it, and that she had lost a significant amount of bone.”

– Lisa Paull v. Cartiva Inc. et al

Paull was presented with the option of either having a new implant installed or undergoing big toe fusion, yet X-rays revealed she had lost too much bone around the Cartiva for another implant to work. She underwent reconstructive surgery in January of this year, losing big toe flexibility and suffering significant loss of work and her active lifestyle, which has significantly altered her life.

The filing presents claims of strict liability, per se negligence, failure to warn, common law product liability and negligence, and breach of warranty. It seeks compensatory damages for past and future medical expenses, lost wages, lost earning capacity, past and future emotional distress and other pain, suffering and loss of enjoyment of life.

Cartiva Failure Lawsuits

Paull’s claim will be consolidated with more than a dozen similar complaints as part of a Cartiva failure lawsuit multidistrict litigation (MDL) in the Eastern District of Arkansas under U.S. District Judge Kristine G. Baker for coordinated discovery and pretrial proceedings.

Judge Baker is expected to propose a series of early test cases, known as bellwether trials, that will put the plaintiffs’ and defendants’ evidence, theories and arguments before actual juries to see how they respond to information likely to be shared across all of the litigation.

While not binding on any other cases, the outcome of these trials would be closely watched to see how juries rule and what types of payouts they award to plaintiffs. This information could be crucial for the parties to hammer out a Cartiva failure lawsuit settlement agreement.

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