Cartiva SCI Lawsuit Alleges Toe Implant Worsened Pain, Decreased Range of Motion

Indiana woman fears that her failed Cartiva Synthetic Cartilage Implant (SCI) may require her to undergo a permanent toe fusion procedure.

An Indiana woman has filed a lawsuit against Cartiva manufacturers, claiming that the synthetic cartilage implant (SCI) was defective and failed to alleviate any pain or stiffness in her big toe, ultimately leaving her in worse condition after receiving the device.

The complaint (PDF) was filed by Laura Kwasny in the U.S. District Court for the Northern District of Illinois on March 26, naming Cartiva, Inc. as the defendant in the latest of a growing number of claims against the medical device manufacturer.

The Cartiva SCI is a molded cylindrical toe implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted by the manufacturer as a revolutionary alternative to fusion surgery for individuals with hallux limitus or hallux rigidus, which are forms of degenerative arthritis in the first joint of the big toe.

Although the device was marketed as a breakthrough treatment option, concerns have emerged about alarming Cartiva failure rates, which have caused some users to experience severe toe pain, loosening of the implant and other problems, often resulting in the need for additional surgery that leaves them with a substantial loss of mobility. These concerns led to a Cartiva recall in October 2024, due to high rates of failure.

Kwasny’s claim now joins other Cartiva SCI lawsuits being pursued by other recipients of the implant, each raising similar allegations that the device was defectively designed and contained known risks that were not disclosed to doctors and patients.

The lawsuit indicates Kwasny received the Cartiva SCI implant in December of 2016. However, after the surgery, she began experiencing worsening pain and decreased range of motion.

Kwasny claims she repeatedly followed up with her doctor about persistent pain, joint erosion and a shortening of her toe. Ultimately, a second opinion led to the discovery that her Cartiva SCI implant had failed, the lawsuit notes.

As a result, she underwent removal surgery, and permanent fusion of her big toe was recommended, which will leave her with a significantly decreased range of motion and potentially further complications. 

In addition to a loss of range of motion of the great toe, Kwasny claims she has experienced loss of mobility, nerve damage and debilitating pain of the great toe, along with constant irritation and discomfort in the location of the artificial Cartiva device. 

“Plaintiff continues to experience significant pain in her foot but is holding off on the recommended fusion surgery as long as possible due to fear of undergoing another surgery,” the lawsuit states. “As a result of the CARTIVA SCI failure, Plaintiff has experienced extreme pain and physical limitations and ongoing medical care.”

Kwasny presents claims of strict product liability and negligence, seeking compensation for damages exceeding $75,000. 

Cartiva Recall Lawsuits

Following the decision to remove Cartiva implants from the market, a growing number of individuals are now reaching out to lawyers to determine whether they may be eligible for financial compensation through a Cartiva injury lawsuit, claiming that they may have avoided painful complications or the need for additional surgery if manufacturers had accurately disclosed the implant’s failure rates.

The first Cartiva lawsuit trial is scheduled to begin on October 28. Earlier this month, a federal judge announced that a second Cartiva SCI trial will be held next February, involving claims by a West Virginia woman who says the implant failed just weeks before the recall was announced.

The outcomes of these trials will be closely watched, but the results will not be binding on any other Cartiva SCI lawsuits.