Cartiva Toe Implant Erosion Resulted in Persistent Pain, Lawsuit Alleges

Implant caused significant bone loss and deformity, requiring a woman’s big toe to be permanently fused into one position.

A Pennsylvania woman alleges she has been left with permanent mobility limitations after her Cartiva toe implant, which was intended to preserve motion in the joint, failed and eroded the surrounding bone so severely that doctors could no longer replace it with another implant.

The complaint (PDF) was filed by Andrea Keller in the U.S. District Court for the Eastern District of Pennsylvania on May 12. It names Cartiva Inc., the implant’s manufacturer, as the sole defendant.

Keller claims Cartiva knew its big toe implant had a substantially higher failure rate than originally advertised and was associated with loosening, persistent pain and bone erosion. However, she goes on to allege that the company concealed those risks from patients, doctors and regulators while continuing to market the device as a safe alternative to toe fusion.

Cartiva Implant Malfunctions

The Cartiva synthetic cartilage implant, or SCI, is surgically placed in the big toe to treat degenerative arthritis conditions such as hallux limitus and hallux rigidus. Made from a polyvinyl alcohol-based gel, the device was promoted as an alternative to permanently fusing the toe joint, which can significantly limit flexibility and mobility.

Cartiva promoted the implant as having an 87% success rate. However, the FDA later announced that real-world data showed the success rate was only between 21% and 46%, meaning most Cartiva SCI implants failed. The findings led to a Cartiva SCI recall in October 2024.

Following the recall, Keller and other former recipients have begun filing Cartiva toe implant lawsuits, alleging they suffered serious complications after the device failed. The complaints describe problems such as chronic pain, implant loosening, fractures, bone damage and complete device failure, often leaving patients with no option other than big toe fusion.

Cartiva Failure Allegations

According to the lawsuit, Keller was first implanted with a Cartiva SCI in January 2019. However, she indicates that she has seen no pain relief or restoration of motion since the procedure.

“As a result of the implantation of the Defective Device, Plaintiff has suffered additional surgeries and medical expenses, including an additional surgery in December of 2024, 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.”

– Andrea Keller v. Cartiva Inc.

Keller claims her injuries could have been avoided had Cartiva provided the medical community and patients with proper warnings. However, the lawsuit alleges that not only did Cartiva know that its failure rates were much higher than advertised, the company actively hid the excessive failures from the public and medical device regulators.

The lawsuit notes that Cartiva was aware of at least 144 such reports of implant failure before December 2025, the month before Keller underwent her procedure. Additionally, Keller indicates that the company knew the gel could erode, causing loosening and erosion of the surrounding bone, yet it failed to add additional warnings or change the design of the device in order to preserve profits.

Keller presents claims of strict products liability design, manufacture and failure to warn, negligence, misbranded and adulterated device, state law and common law claims of product liability and negligence for class II devices/class III devices, breach of warranty, failure to warn. She seeks both compensatory and punitive damages.

Cartiva Toe Lawsuits

The claim will be consolidated with more than a dozen similar Cartiva failure lawsuits as part of a multidistrict litigation (MDL), in the Eastern District of Arkansas, where U.S. District Judge Kristine Baker is ushering the litigation through coordinated discovery and pretrial proceedings.

It is anticipated that Judge Baker will propose a series of early test cases, known as bellwether trials, which will put strengths and weaknesses of the parties’ cases before a live jury. The outcome of these bellwether trials, while not binding on the other lawsuits, could be crucial in helping the parties reach a settlement agreement.

However, if the bellwether trials and pretrial proceedings conclude with no Cartiva toe lawsuit settlement or other resolutions for the remaining claims, the judge may remand the cases back to their originating districts for individual trial dates.

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