Contact Bailey, Javins, and Carter, LC, and Take Your First Step Toward Securing Justice

Understanding the Cartiva Lawsuit: Relief That Turned Into Risk

The Failed Promise of Toe Arthritis Relief

For years, individuals suffering from debilitating big toe arthritis sought a middle ground between constant pain and the restrictive nature of traditional “fusion” surgery. The Cartiva Synthetic Cartilage Implant (SCI) was presented as that perfect middle ground. Marketed as a revolutionary gel-like device, it was intended to mimic natural cartilage, allowing patients to retain their range of motion while eliminating the “bone-on-bone” friction caused by arthritis.

However, for a significant number of patients, this medical advancement has resulted in a traumatic cycle of chronic pain and corrective procedures. At Bailey, Javins, and Carter, LC, we have watched this situation unfold with deep concern. We believe that when a medical device manufacturer prioritizes market share over patient safety, they must be held legally and financially responsible. If you are struggling with a failed Cartiva implant, you are not alone, and there are legal avenues available to help you recover your losses.

What is the Cartiva Synthetic Cartilage Implant?

The Cartiva SCI is a small, cylindrical device made from a polyvinyl alcohol hydrogel. It was designed to treat hallux rigidus, a form of degenerative arthritis that affects the base of the big toe. By surgically inserting this “plug” into the joint, surgeons hoped to provide a cushioning effect similar to human cartilage.

The device received FDA approval in 2016 and was quickly adopted by orthopedic surgeons across the country. Because it did not require the permanent fusing of bones, it was highly attractive to active patients who wanted to keep their toes flexible. Unfortunately, the real-world performance of the device has failed to live up to the clinical expectations set by the manufacturer, Cartiva, Inc. (a subsidiary of Stryker Corporation).

The Shocking 2024 Recall and Failure Rates

While some medical devices face issues in a small percentage of patients, the statistics surrounding the Cartiva SCI are particularly alarming. Independent research and mounting patient data suggest that the implant may fail in as many as two-thirds of all cases. This is a staggering failure rate for a permanent medical fixture.

The situation reached a breaking point on October 31, 2024, when a formal recall was issued for the device. The primary reasons cited for the recall included high rates of implant shrinkage, loosening, and “subsidence”—a condition where the device actually sinks into the bone. This recall has left thousands of patients wondering if the device currently in their bodies is a ticking time bomb and why it took nearly a decade for the manufacturer to address these obvious defects.

Common Complications and Symptoms of Failure

Patients who have received a Cartiva implant should be vigilant for signs of failure. The most common complications reported in recent lawsuits include:

• Severe Bone Loss (Subsidence): The implant can migrate or sink deep into the metatarsal bone, causing structural damage to the foot.
• Persistent Inflammation: Many patients report that their toe remains swollen and painful long after the initial recovery period should have ended.
• Loss of Mobility: Rather than improving movement, a failing implant often makes it impossible to walk comfortably or wear standard shoes.
• The Need for Revision Surgery: In many cases, the only way to fix a failed Cartiva implant is to remove it and perform the very “fusion” surgery the patient was trying to avoid in the first place.

Why Families Are Filing Lawsuits

The legal claims against Cartiva, Inc. and Stryker focus on more than just a “bad product.” The lawsuits allege that the manufacturers knew—or should have known—about the high failure rates long before the 2024 recall. Claims typically include design defects, where the material itself is deemed unfit for the mechanical stress of a human joint, and “failure to warn.”

By allegedly withholding negative data from doctors and the public, the company deprived patients of the ability to make an informed choice about their health. Pursuing a lawsuit allows victims to seek compensation for medical bills, the cost of future surgeries, lost wages due to recovery time, and the physical pain and suffering they have endured.