Cartiva Surgery Lawsuit Claims SCI Implant Failure Required Big Toe Fusion

Lawsuit alleges a Cartiva synthetic cartilage implant failed within a single year, causing chronic pain, stiffness and bone loss.

A West Virginia woman alleges her defective Cartiva Synthetic Cartilage Implant (SCI) failed and left her needing a permanent fusion of her left big toe, despite claims that the device could help patients avoid that surgery.

The complaint (PDF) was brought by Celena Luster in the U.S. District Court for the Northern District of West Virginia on May 14, naming Cartiva Inc. as the defendant.

Luster claims that a defective Cartiva SCI was marketed to her as a motion-preserving alternative to big toe fusion surgery. However, the product failed within a year of being implanted, causing chronic pain, stiffness, bone loss and limited mobility that required surgeons to remove the device and permanently fuse the joint. 

Cartiva SCI Failure Risks

The Cartiva Synthetic Cartilage Implant was developed to treat hallux limitus and hallux rigidus, degenerative forms of arthritis affecting the big toe. Made from a polyvinyl alcohol-based hydrogel, the device was marketed as a motion-preserving alternative to fusion surgery, which permanently locks the joint in place.

However, after mounting reports of complications and evidence suggesting the implant failed far more often than initially disclosed, the U.S. Food and Drug Administration (FDA) announced a Cartiva recall in October 2024.

The recall has fueled a growing number of Cartiva surgery lawsuits filed by patients who allege they suffered severe toe pain, implant loosening, bone loss and other complications after receiving the device. In many cases, the failures reportedly left patients with no option other than surgery to permanently fuse the big toe, resulting in a significant loss of mobility.

Cartiva Implant Failure Allegations

According to the lawsuit, Luster underwent Cartiva surgery on December 21, 2020, at West Virginia University Medicine, where the device was implanted in her left big toe. The complaint says she chose the implant after being told it would provide faster recovery and preserve movement compared to traditional fusion surgery.

Instead, Luster allegedly developed chronic pain, stiffness and limited range of motion in her foot. Less than one year later, on December 20, 2021, surgeons removed the implant and fused the bones in her big toe together permanently. During the revision surgery, doctors reportedly found significant scarring, osteophytes and breakdown of the cartilage in the joint, which the complaint says is consistent with known Cartiva failure mechanisms.

The lawsuit alleges Cartiva knew long before Luster’s surgery that the device was associated with much higher failure rates than disclosed in its clinical studies and marketing materials. The complaint cites published research and physician reports suggesting that actual failure rates may have been 64%, far above the 13.5% rate reported to the FDA.

Luster further claims Cartiva promoted the implant as a quick, minimally invasive procedure that would reduce pain and preserve toe motion, while failing to adequately warn patients and physicians about the risks of implant shrinkage, migration, bone erosion, loss of mobility and the need for additional surgeries.

“As a result of the implantation of the Defective Device, Plaintiff has suffered additional surgeries and medical expenses and the removal of the implant and subsequent surgery to ‘fuse’ her big toe bones together, all of which was needed to correct the toe deformity and bone loss caused by the Defective Device, and causing additional loss of income, loss of enjoyment of life, and pain and suffering.”

— Celena Luster v. Cartiva Inc.

The complaint raises allegations of strict products liability, negligence, misbranded and adulterated device, breach of express and implied warranties, failure to warn, and violations of various state laws. It seeks compensatory and punitive damages.

Cartiva Implant Recall Lawsuits

Luster’s lawsuit will be transferred to the federal Cartiva failure multidistrict litigation (MDL), where more than a dozen similar complaints have been centralized before U.S. District Judge Kristine G. Baker in the Eastern District of Arkansas for coordinated discovery and pretrial proceedings.

Judge Baker is expected to establish a series of early bellwether trials, which will allow juries to hear representative claims and help both sides gauge how evidence and testimony may be viewed in cases throughout the MDL.

Although the results of these test trials will not directly determine the outcome of other lawsuits, they are expected to play an important role in shaping negotiations over a potential Cartiva lawsuit settlement.

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