Lawsuit Indicates Cartiva Toe Implant Revision Rates ‘Alarmingly High’

According to a new lawsuit, the manufacturer knew Cartiva revision rates were higher than advertised shortly after the device hit the market.

A newly filed lawsuit alleges that a Cartiva toe implant failed within about a year of implantation, despite manufacturer claims of low revision rates, which were later called into question in 2024 when the device was removed from the market following growing reports of implant failures.

Marion Bhatt’s complaint (PDF) was brought in the U.S. District Court for the Eastern District of North Carolina on March 26, naming Cartiva Inc. as the sole defendant.

The Cartiva synthetic cartilage implant (SCI) is a polyvinyl alcohol-based hydrogel device that was designed and marketed as a means of treating hallux limitus and hallux rigidus, both forms of degenerative arthritis that affect the big toe. About 2.2 million people in the United States are estimated to be living with the conditions.

The device was approved by the U.S. Food and Drug Administration (FDA) in 2016, based in part on the results of a clinical trial known as the “MOTION Study,” which involved 152 Cartiva toe implant procedures. According to the study, there was no evidence of fragmentation, material degradation or bone loss.

However, Bhatt’s lawsuit indicates that once the device entered the market, the company began receiving numerous adverse event reports describing very different real-world performance. In addition, physicians were reporting significantly higher Cartiva revision rates than those originally presented.

Ultimately, the manufacturer announced a Cartiva recall in October 2024, after admitting the device suffered a “higher-than-expected” failure rate. Now, a growing number of Cartiva toe implant lawsuits are being filed indicating that the manufacturer knew, or at least should have known, that the Cartiva revision rates in the clinical study were dubious at best.

Cartiva Toe Implant Failure

According to the lawsuit, Bhatt received a Cartiva toe implant in her right big toe in May 2018, at a time when the manufacturer continued to promote the device as having very low failure rates. 

By May 2023, the implant had failed, requiring revision and fusion surgery. Following the procedure, the surgeon reportedly noted that “the bone surrounding the implant, especially dorsally and medially, was quite unhealthy.” Bhatt later underwent a second fusion surgery in August 2025.

The lawsuit further alleges that the manufacturer had long been aware that Cartiva revision rates were significantly higher than advertised. While the company claimed a failure rate of about 13.5%, a 2020 study of real-world outcomes found failure rates closer to 65%, suggesting Bhatt’s experience was far from uncommon. 

The complaint claims the company knew of these risks and failed to disclose them to doctors and patients.

“Prior to the implantation of Plaintiff’s Cartiva implant, Defendant was aware of higher than reported loss of toe mobility, pain, and high failure rates of the Cartiva implant due to shrinkage including but not limited to over 144 adverse event reports filed with the FDA.”

– Marion Bhatt v. Cartiva Inc.

Bhatt indicates that the failed Cartiva toe implant caused additional surgeries, including an osteophytectomy as early as 2019, only one year after the implantation procedure. She also required big toe fusion to address the toe deformity and bone loss caused by the implant, which the device was supposed to help her avoid.

The lawsuit presents claims of failure to warn, negligence – design, manufacture, misbranded and improper transfer of 510(k)/PMA without FDA approval, misbranded and adulterated device, and breach of warranty.

Cartiva Toe Implant Lawsuits

Bhatt’s complaint will be consolidated with other lawsuits over Cartiva toe implant failures in the Eastern District of Arkansas, as part of a multidistrict litigation (MDL) before U.S. District Judge Kristine G. Baker, who will oversee coordinated discovery and pretrial proceedings.

Judge Baker is expected to eventually order the parties to prepare a series of cases for early “bellwether” trial dates, which will give them an opportunity to see how juries respond to arguments, evidence and testimony likely to be repeated throughout the litigation.

While not binding on any other lawsuits, bellwether trials are closely watched, as they often help form the basis of settlement negotiations. However, if the trials and pretrial proceedings end with no Cartiva SCI toe implant lawsuit settlement, Judge Baker would likely begin remanding the cases back to their originating districts for individual trial dates.

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