Cartiva Lawsuit Filed After Toe Implant Failure Results in Need For Fusion Surgery

Lawsuit alleges Cartiva toe implant is unreasonably dangerous and defective, causing complications when the implant loosens and fails

A product liability lawsuit claims the Cartiva Synthetic Cartilage Implant (SCI) used to treat pain and cartilage loss due to big toe arthritis, is defectively designed and prone to fail, resulting in severe pain and the need for additional surgery that can result in long-term disability and injuries.

The complaint (PDF) was filed by Cathy Atkinson last month in the U.S. District Court for the Western District of Texas, presenting claims against the toe implant manufacturers, Cartiva Inc, Wright Medical Group, and Stryker, indicating that they marketed an unreasonably dangerous product, without disclosing known risks.

The Cartiva SCI is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted as a revolutionary toe implant since it was introduced.

However, only a few years later the toe implant failure rates have caused widespread complications, including reports of severe toe pain, loosening, fracture and other problems, often result in the need for a toe fusion surgery. As a result, a growing number of recipients have begun filing Cartiva implant failure lawsuits against the manufacturer over the need for additional revision and replacement surgeries.

The Cartiva toe implant is placed in the first joint of the big toe, known as the first metatarsophalangeal joint, when arthritis has caused the cartilage in that joint to degrade, which can result in severe pain. The condition is known as hallux limitus or hallus rigidus. It affects about 2.2 million people in the U.S.

The synthetic cartilage implant is designed to provide cushioning to replace the degraded cartilage and provide pain relief. It is considered an alternative to fusing the joint, a procedure known as arthrodesis, which has a longer healing time and is a more complicated surgical procedure.

According to the lawsuit, Atkinson underwent Cartiva SCI implant surgery in November 2018. However, just two years later, Atkinson was told the device had failed, resulting in revision surgery in December 2020 to have the device removed.

She had to undergo arthrodesis fusion surgery in 2021 due to severe pain.

Cartiva SCI Complications

The Cartiva SCI received premarket approval based on its “substantial equivalence” to arthrodesis. However, the lawsuit points out that they are completely different procedures. Results of a clinical study leading to approval, known as the “Motion” study, was a non-inferiority clinical trial comparing the implant to arthrodesis. However, the results have never been duplicated and the failure rate is much higher than the Motion study predicted, according to follow-up studies.

One such study, published by researchers from Cedar Sinai Hospital in 2019, found that 30% of Cartiva SCI recipients were either dissatisfied or very dissatisfied with the outcomes of the procedure. The study found 50% required a corticosteroid injection after the receiving the implant.

“Synthetic cartilage implantation yielded modest patient satisfaction, mild dysfunction in physical measures, and a large proportion requiring further treatment and workup post operatively,” the researchers concluded. “We believe patient selection and counseling on the potential for continued pain and dysfunction in the early postoperative period following this procedure are important before proceeding with synthetic cartilage implantation for hallux rigidus.”

“The Cartiva implant surgical procedure has not been effective at alleviating pain or restoring range of motion,” Atkinson’s lawsuit states. “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.”

Risk of Cartiva Toe Implant Failures Not Adequately Disclosed

The lawsuit notes there have been at least 144 adverse event reports linked to the Cartiva SCI submitted to the FDA. The majority of complaints were linked to implant loosening, which the lawsuit claims is likely due to shrinkage of the implant caused by PVA degradation.

While the implant’s warning label indicates it has a 13.5% failure rate, the lawsuit indicates the actual failure rate is likely six to seven times higher, and claims the defendants intentionally underreported the failure rate to the FDA.

In addition to implant loosening, Cartiva SCI complications have been linked to persistent pain, infection, implant fracture, osteolysis, bone over-production, cyst formation, silastic granulomas and transfer metatarsalgia. In some cases, device failure could lead to joint removal.

Atkinson’s lawsuit presents claims of negligent design, improper use of the FDA’s controversial 510(K) premarket approval process, which requires a device only be “substantially equivalent” to an existing procedure or device; claims of misbranding an adulterated device, as well as claims of negligence, breach of warranty, failure to warn, violations of the Texas Deceptive Trade Practices Act, and seeks compensatory and punitive damages.