Lawsuit Alleges Cartiva Synthetic Cartilage Implant Failure Led to Additional Toe Surgery

Cartiva manufacturers allegedly overhyped the toe implant’s success rates until the device was removed from the market.

An Alabama man has filed a product liability lawsuit claiming the makers of the Cartiva Synthetic Cartilage Implant (SCI) knew for years that the big toe implant was defectively designed and prone to failure, yet continued to market it despite obvious failings.

The complaint (PDF) was brought by Ronald G. Ryals in the U.S. District Court for the Northern District of Florida on October 29, naming Cartiva Inc., Wright Medical Group N.V. and Stryker B.V. as defendants.

Ryals alleges he had to undergo additional surgeries after his Cartiva toe implant failed, resulting in injuries and a loss of mobility because the manufacturers were dishonest about the implant’s success rates, having claimed that most of the procedures were a success, when many were actually failures.

Cartiva SCI Problems

The Cartiva SCI was first approved in 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of patients suffering from degenerative and post-traumatic arthritis, known as hallux limitus and hallux rigidus. Constructed of polyvinyl alcohol-based gel, the big toe implants claimed to be a viable alternative to having the big toe simply fused in place, which is the typical solution, but significantly reduces mobility.

The manufacturers marketed the Cartiva SCI as having a 97% pain reduction rate and an 87% success rate. However, the implant, which was supposed to be permanent, quickly began showing signs of design problems.

The FDA announced a Cartiva SCI recall in October 2024, after determining that the actual success rate of the implants only ranged from 21% to 46%. A growing number of recipients are now pursuing Cartiva lawsuits indicating there is no way the manufacturers made such an overestimation by accident, alleging the Cartiva problems were known but hidden from the public to increase the company’s profits at patients’ expense.

Cartiva Synthetic Cartilage Implant Failure Allegations

According to the complaint, Ryals received a Cartiva Synthetic Cartilage Implant in September 2018 to treat hallux rigidus, a condition that causes pain and stiffness in the big toe joint of his right foot. However, the lawsuit alleges the implant failed to provide the pain relief and improved mobility he was led to expect.

Instead, Ryals claims he continued to experience significant pain and limited range of motion, along with worsening joint deterioration and restrictions on his daily activities. The lawsuit maintains that the implant failed to deliver the benefits advertised by Cartiva, leaving him with ongoing foot problems.

The complaint indicates that Cartiva began receiving reports of implant failures as early as 2019, approximately one year after Ryals underwent his procedure. By that time, some doctors had reportedly begun questioning the implant’s effectiveness and reducing their use of the device after observing outcomes that fell short of the manufacturer’s advertised success rates.

The lawsuit further alleges that subsequent clinical data revealed Cartiva SCI failures were substantially more common than initially reported, raising concerns that the manufacturer had understated the risks and overstated the implant’s long-term effectiveness.

“Problems with post-operative pain, degree of motion, or the device slipping into the bone in a process known as subsidence (“shrinkage”) were reported. Doctors have been unable to replicate the positive results of the company’s Motion Study in the broader patient population and have stopped implanting the device or are more cautious about using it.”

– Ronald Ryals v. Cartiva Inc. et al.

Ryals indicates he suffered significant loss of use of his big toe and now has restricted range of motion that limits his activities. The lawsuit does not say if the device has yet been surgically removed.

The filing presents claims of strict product liability, negligent design, misbranded and adulterated device, failure to warn, common law product liability and negligence, and breach of warranty. It seeks compensatory and punitive damages.

Cartiva SCI Lawsuits

Ryal’s complaint will be consolidated with similar Cartiva SCI lawsuits in the Eastern District of Arkansas before U.S. District Judge Kristine Baker for coordinated discovery and pretrial proceedings as part of a multidistrict litigation (MDL).

The judge is eventually expected to order counsel to select several trials to serve as representative bellwether cases that will present evidence likely to be used throughout the litigation before a live jury to see how they process the witnesses and testimony presented. The outcomes, while not binding, could help attorneys find common ground in settlement discussions.

If no resolution is found by the end of these bellwether trials, the claims will likely be remanded back to their original districts to be prepared for trial.

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