Cartiva Toe Implant Failures: Your Path to Justice Starts Here

Cartiva Lawsuit

For countless patients seeking relief from big toe arthritis, the Cartiva Synthetic Cartilage Implant (SCI) promised a revolutionary solution—pain relief and preserved mobility without the drawbacks of traditional fusion surgery. Marketed by Cartiva, Inc. (now part of Stryker Corporation), this gel-like device was meant to replace damaged cartilage in the first metatarsophalangeal (MTP) joint. Yet, for many, that promise has turned into a nightmare of persistent pain, implant failure, and costly revision surgeries.

At Bailey, Javins, and Carter, LC, we’re committed to holding manufacturers accountable when their products harm rather than heal, and the Cartiva SCI is a troubling example of such a failure.

If you or a loved one has suffered complications from a Cartiva implant, you may be entitled to significant compensation. Contact us today at 800-497-0234 for a free consultation to explore your legal options.

The Cartiva SCI Controversy: A Flawed Solution

The Rise and Fall of a Modern Medical Solution

The Cartiva Synthetic Cartilage Implant (SCI) was once heralded as a breakthrough for patients suffering from hallux rigidus. This condition, characterized by the degeneration of cartilage in the metatarsophalangeal (MTP) joint at the base of the big toe, results in debilitating stiffness, bone spurs, and chronic pain. For decades, the standard of care for end-stage hallux rigidus was arthrodesis, or toe fusion. While fusion effectively eliminates pain by joining the bones together, it permanently removes the joint’s range of motion, making it difficult for patients to run, wear certain footwear, or engage in activities requiring toe flexibility.

In 2016, the FDA granted Premarket Approval (PMA) to the Cartiva SCI. Composed of a proprietary polyvinyl alcohol (PVA) hydrogel, the device was designed to mimic the physical properties of natural human cartilage. The surgical appeal was significant: a minimally invasive procedure that required removing a small amount of bone and replacing it with a “plug” that would cushion the joint. The promise was clear—relief from arthritic pain without the restrictive permanence of a fusion. Unfortunately, for thousands of patients, this promise transformed into a cycle of revision surgeries and permanent physical damage.

A Flawed Design: Understanding the Mechanism of Failure

Independent clinical reviews and post-market surveillance have painted a much darker picture than the initial data suggested. While the manufacturer, Cartiva, Inc. (and its parent company, Stryker), marketed the device as having a high success rate comparable to fusion, real-world applications told a different story. Reports indicate that the implant fails at an alarming rate, with some data suggesting that nearly one in three patients—and in some specific cohorts, up to two-thirds—suffer from significant complications.

The primary issue lies in the device’s stability within the bone. Unlike a fusion, which creates a solid bridge of bone, the Cartiva implant relies on “press-fit” stability. Over time, many patients have discovered that the hydrogel does not maintain its integrity. It can shrink, lose its shape, or, most commonly, subside. Subsidence occurs when the implant sinks into the metatarsal head, effectively disappearing into the bone it was meant to protect. When the device migrates or sinks, the “bone-on-bone” contact returns, often with greater severity than before the surgery.

Common Complications and Patient Impact

The clinical fallout for those with a failing Cartiva SCI is often catastrophic. Because the big toe is essential for balance and the “push-off” phase of walking, a failure in this joint affects the entire kinetic chain of the body. Patients often report the following issues:

1. Implant Subsidence and Migration: As the device loses its structural integrity, it can move within the joint or collapse into the bone. This often leaves behind a significant “void” or hole in the bone, making subsequent repairs extremely difficult.
2. Persistent and Worsening Pain: Many individuals find that their post-operative pain exceeds their original arthritic discomfort. This is often the result of the body’s inflammatory response to a degrading foreign object or the mechanical failure of the joint.
3. Significant Bone Loss: When the Cartiva SCI fails, it often erodes the surrounding bone. For patients who eventually seek the fusion surgery they were trying to avoid, surgeons often find there is not enough healthy bone left to perform a standard fusion, necessitating bone grafts and longer recovery periods.
4. Cyst Formation: The presence of the hydrogel has been linked to the development of subchondral cysts and “radiolucency,” which indicates a lack of integration between the implant and the patient’s natural anatomy.

The 2024 Recall: A Turning Point

On October 31, 2024, the medical community received a formal confirmation of these risks. A recall was issued for the Cartiva SCI due to the high rates of failure and the necessity for revision surgeries. This recall validated the concerns that patients and surgeons had been voicing for years. However, for many, the action came far too late.

The legal questions now center on what the manufacturer knew and when they knew it. Evidence suggests that the discrepancy between the company’s internal data and the actual patient outcomes was known long before the formal recall. The delay in taking action allowed thousands of more devices to be implanted into unsuspecting patients, many of whom are now facing permanent disability or the need for complex reconstructive foot surgery.

Legal Claims and the Pursuit of Accountability

The litigation currently mounting against Cartiva, Inc. and Stryker is focused on several key legal theories designed to hold medical device manufacturers responsible for the safety of their products. These claims typically include:

Design Defects

Plaintiffs allege that the Cartiva SCI is inherently dangerous in its design. The argument is that the PVA hydrogel is not a suitable material for the high-pressure environment of the MTP joint, which must bear the weight of the entire body during movement. The propensity for the material to shrink or subside suggests a fundamental flaw in the product’s engineering.

Failure to Warn

A significant portion of the litigation involves the “Failure to Warn” doctrine. Under this theory, a manufacturer has a legal obligation to inform both doctors and patients of all known risks associated with a device. Allegations suggest that Cartiva, Inc. downplayed the revision rate and failed to disclose the high frequency of subsidence observed in clinical settings, thereby preventing patients from making a truly informed choice.

Negligent Misrepresentation

By marketing the SCI as a “revolutionary” alternative to fusion while allegedly possessing data that suggested otherwise, the company is accused of misrepresenting the safety profile of the device. This includes claims that the company prioritized market share and profit over the long-term health outcomes of the patient population.

Seeking Legal Redress

For those harmed by a defective medical device, the legal system provides a pathway to recover damages for medical expenses, lost wages, and pain and suffering. At Bailey, Javins, and Carter, LC, our lawyers have a history of representing individuals who have been injured by faulty medical implants. Our firm focuses on product liability and personal injury litigation, providing a voice to those who have been marginalized by large medical corporations.

When you contact our firm, you will speak with attorneys who handle complex medical litigation and are dedicated to investigating the specifics of each Cartiva claim. We focus our practice on holding manufacturers accountable for the safety of the devices they bring to market. Our legal team is currently reviewing cases for individuals who have undergone revision surgery following a Cartiva implant or have been told by their doctor that their implant has failed, migrated, or caused bone loss.

The transition from a “minimally invasive” promise to a “major reconstructive” reality is a traumatic experience. We believe that no patient should have to bear the financial and physical burden of a manufacturer’s failure to provide a safe product. Our advocates are here to help you navigate the complexities of the legal process and pursue the compensation you deserve.

The Toll on Patients

Beyond physical pain, Cartiva’s failures impose emotional and financial burdens. Revision surgeries rack up bills, while limited mobility disrupts daily life—walking, working, or simply enjoying time with family. For example, patients like Robert Connor of Chevy Chase, Maryland, (featured in a prominent lawsuit), illustrate the human cost of this defective product. As litigation grows, it’s clear this isn’t an isolated issue but a widespread problem affecting hundreds, if not thousands, of implant recipients.

Pursuing a Cartiva Lawsuit

Filing a product liability lawsuit involves proving the implant was defective, caused your injuries, and resulted in damages like medical expenses or lost wages. Our experienced attorneys can gather medical records, consult experts, and build a case. Time is of the essence though. Legal deadlines vary by state and can limit your ability to seek justice, so acting promptly is very important.

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

If you’ve suffered from ongoing pain, limited mobility, or the need for revision surgery after a Cartiva toe implant, you don’t have to face this ordeal alone. At Bailey, Javins, and Carter, LC, we’re at the forefront of this litigation, we are currently accepting cases. Our team is dedicated to securing the compensation you deserve for medical costs, pain, and suffering.

Please contact us today for a free consultation to learn more about your legal options and how we can fight for you.