As impressive as this all sounds, we still struggle to mimic what Mother Nature does so easily: the biomechanics of the human body. For example, in 2016, Cartiva, Inc. developed a synthetic cartilage implant (SCI) designed to address pain and reduced range of motion of the first metatarsophalangeal joint (often caused by arthritis). This is the joint where your big toe connects to the rest of your foot.

Unfortunately, the Cartiva SCI failed to meet expectations, which I wrote about last summer. Since publishing that blog post, there have been a few notable developments, including a medical device recall and a number of lawsuits getting close to trial.

The Cartiva Toe Implant Recall

On Halloween of 2024 (coincidence, I hope), Stryker issued a medical device recall of its Cartiva SCI. Stryker didn’t create the artificial cartilage implant, but Stryker acquired the Wright Medical Group NV (Wright) in 2020, and Cartiva, Inc. was a whole owned subsidiary of Wright.

The recall affected 6mm, 8mm, 10mm and 12mm sized implants distributed from July 2016 to October 2024. This amounted to a total recall and withdrawal of all Cartiva SCIs from the market. Stryker stated this recall was due to a higher-than-expected rate of problems with the implant, including the implant coming lose and moving out of place. It’s not fully known why this occurs, but potential reasons include the SCI being too smooth, shrinking, or not being properly held in place due to a weakened bone structure.

The Rise in Cartiva SCI Lawsuits

Even though the recall took place in 2024, problems with the implant had been known well beforehand. Problems with the SCI were being reported in published scientific papers as early as 2022. At least six lawsuits were filed in 2022, although some of these were voluntarily withdrawn without prejudice. “Without prejudice” means the plaintiffs could re-file their lawsuits in the future.

It’s been suspected, but not confirmed, that these cases were close to settlement or that the parties agreed to a tolling agreement. A tolling agreement is where parties to a lawsuit agree to pause the applicable statute of limitations. This can potentially provide more time for each side to negotiate a settlement or obtain more information. Despite these dismissals, more lawsuits were filed in 2024 and 2025, including the following federal cases:

• May v. Cartiva, Inc., Case No. 2:24-cv-00687
• Krolicki v. Cartiva, Inc., Case No. 1:25-cv-03415
• Peachey v. Cartiva, Inc., Case No. 2:25-cv-01217
• Hughes v. Cartiva, Inc., Case No. 2:24-cv-00319

At the beginning of 2025, it appeared as if many of these cases would go to trial or settle, but as the year goes on, this seems less likely. For instance, the Hughes case was originally scheduled for an October 28, 2025 trial, although this date was pushed back to May 26, 2026. The May case has also been delayed, with a trial date rescheduled from February 2026 to August 2026.

Allegations Made in Toe Implant Cases

Plaintiffs suing Cartiva, and/or Stryker and Wright have based their claims on one or more of the following causes of action:

• Strict product liability
• Negligence
• Misbranded and adulterated device
• Breach of express warranty
• Breach of implied warranty
• Failure to warn

Notable arguments include Cartiva misrepresenting the failure rates of the SCI, failing to properly study how the implant would perform in humans and failing to warn prospective patients of the risks of receiving this implant.

What’s Next for Cartiva?

Presumably, lawsuits will continue to be filed while a case or two goes to trial or settles. But how long it takes to actually get a trial or settlement is unknown. Then there’s the fact that new cases are consistently getting filed.

If you received a Cartiva SCI and haven’t already done so, talk to your doctor about any problems you might be having. The most common solution for problems with the Cartiva toe implant has been toe fusion surgery. This is where the bones of the big toe are fused together. This can offer pain relief, but could result in a more limited range of motion.

In addition to talking to your doctor, you might want to talk to an attorney. I’m more than happy to set up a consultation, which you can schedule by using the online contact form or calling (919) 830-5602 (direct line). Good luck.

The Cartiva toe implant has become a commonly used device aimed at relieving symptoms of arthritis in the big toe. It has, however, been known to fail at an abnormally high rate, causing pain, loss of motion, and even additional surgery. If you or someone you know has experienced adverse health effects from receiving the Cartiva toe implant, you may want to keep reading. About the Cartiva Implant

The Cartiva toe implant was manufactured to treat symptoms of big toe arthritis. This type of arthritis occurs when cartilage is damaged, or worn down, in the big toe joint. The degraded cartilage causes the bones to rub together, which can lead to pain, stiffness, and swelling. The Cartiva implant is a synthetic replacement for the degraded cartilage. Its primary purpose is to reduce bone-on-bone friction in the metatarsophalangeal joint in the big toe. It is specifically molded from Polyvinyl Hydrogel (PVA Hydrogel), and is roughly the size of a popcorn kernel. Prior to this implant, the only viable treatment option for big toe arthritis was a difficult fusion surgery that left the patient with limited mobility. This product became the first openly accessible alternative to fusion surgery.

Problems with the Cartiva Implant

The primary issue with the Cartiva toe implant is that it has a high rate of failure. The material, PVA Hydrogel, has a tendency to compress after being implanted. The shrinkage of the implant then leads to migration, and often results in the implant shifting out of position. When the implant moves out of place, it can cause nerve damage and result in extreme pain. Additional surgery must then be conducted to alleviate the pain and correct the PVA Hydrogel implant. In addition to pain, and additional surgery, there are also other negative health impacts of a failed Cartiva implant including infections, osteolysis (bone degeneration), cysts, and silastic granulomas (a skin tissue condition).

Basis of Cartiva Litigation

Cartiva, Inc. was the company who originally developed the Cartiva toe implant. Stryker, a global healthcare and medical device company, acquired Cartiva, Inc. in 2019 and is now the manufacturer of the Cartiva toe implant. The product was approved through a pre-market approval system. However, reports indicate that the company may not have disclosed to the FDA or the public data indicating a higher failure rate. The product label claims the failure rate is 13.5%, but this number is significantly lower than the actual reported rate of failure, with some studies indicating failure rates in excess of 50%. Stryker has not (yet) acknowledged concerning issues with the product. The company has made no effort to revise its warning label, nor does the company have plans for product recall. The failure rate and complicated health risks associated with the Cartiva implant are so significant that some health insurance agencies have refused to cover it, as they deem the implant an ‘experimental’ medicine. Individuals who have had adverse health effects after receiving the Cartiva implant have begun to file lawsuits across the country. The litigation is based on the allegation that Stryker knew about the potentially high failure rates but failed to properly warn the consumer. The volume of these cases is increasing.

If you or a loved one received the Cartiva toe implant and were met with detrimental health effects, first talk to your doctor. If you are interested in pursuing legal action, do not hesitate to reach out to Attorney Clay Hodges at (919) 830-5602 for a consultation.

Note: This blog post was written based on research utilizing the FDA website and online news sources.