A company named Cartiva made a product they named creatively, Cartiva. The flagship product, the Cartiva toe implant, filed an application with FDA in 2015. Cartiva obtained FDA approval in 2016.

Cartiva excited several surgeons. They hoped they had a solution for patient pain. Starting in 2020, concerns about Cartiva arose quietly among some doctors. Cartiva continued selling and patients continued hurting.

Finally, eight years after it hit the market, the Cartiva saga is coming to an end. Cartiva is off the market.

Cartiva Toe Implant Recall and Market Withdrawal

Stryker issued an urgent safety notification and recall for the Cartiva Toe Implant, a Synthetic Cartilage Implant (SCI). Announced October 31, 2024, this marks a critical development for patients, surgeons, and hospitals across the United States. The recall follows new post-market data revealing higher-than-expected rates of adverse outcomes, including revision surgeries, implant failures, and other complications.

A True Recall In the Usual Sense – the Cartiva Toe Implant is Off the Market

Although many people think a product “recall” involves taking product off the shelves, that is not always the case. That’s true particularly with medical devices. Many “recalls” are really just notices or modifications to the instructions for use (e.g., indications, instructions, warnings). Removing the product from the market entirely can be part of a recall, but isn’t always.  Here, Stryker is removing the Cartiva toe implant from the market, truly calling it back from the shelves.

Stryker Is Doing the Right Thing by Withdrawing Cartiva Toe Implants

Stryker did  not design or initially sell the Cartiva toe implant. Rather, a group of people had the idea, deployed the concept in various ways in Europe, and started a company called, Cartiva. They decided to create the Cartiva toe implant. Cartiva would become a big deal in the podiatric and toe implant world, for a bit.

Cartiva sought and obtained FDA approval in the US. They presented data from a study known as the MOTION study. The suggestion was that Cartiva failed in a small number of patients, less than 10% of the time. FDA approved the Cartiva toe implant in 2016.

Another company bought Cartiva. Then Stryker acquired the Cartiva toe implant from that company. Stryker continued to sell Cartiva until this recall.

In 2020, reports emerged that Cartiva was not functioning in patients as expected. Doctors reported having to remove the Cartiva toe implant because it was not providing promised pain relief and causing problems. Surgeons moved away from the Cartiva toe implant. By now it seems widely accepted that Cartiva fails many times more than originally represented. Because it fails so much, Stryker made the right decision to recall and remove it.

KBA Attorneys Has Been Leading the Charge Against the Cartiva Toe Implant

KBA Attorneys have extensive experience as medical device attorneys. Not surprisingly, KBA Attorneys has been at the forefront of the Cartiva from the very beginning. KBA discovered the problem years before some other law firms jumped into the fray.

We monitor FDA regulatory activity and peer review literature. After interning at the FDA, one of KBA’s founder went on to work as a product liability attorney representing companies. Then he switched sides to  represent people medical devices injured. He developed an expertise in post market surveillance by working with leading industry experts. This gives KBA a unique advantage and helps us find emerging cases like the Cartiva toe implant.

After learning about Cartiva, we did our due diligence. Our attorneys spoke with surgeons who implanted Cartiva. We engaged experts who removed the Cartiva toe implant. Digging into the Cartiva pre-market clinical study and post market data, we thought we had a case.

Obviously we at KBA now feel vindicated and are ecstatic for our Cartiva clients. This decision also bolsters our legal arguments against defenses we anticipated like preemption, an issue with which our attorneys, including the partner leading the charge against Cartiva, Whitney Butcher, have handled in other cases, including BHR hip implants.

At KBA Attorneys, we are committed to helping individuals navigate the complexities of medical device recalls and the legal ramifications. Our team has extensive experience with medical device litigation, including Cartiva-related issues, and we are here to support you if you or a loved one has been affected by this device.

What Is the Cartiva Toe Implant?

The Cartiva Synthetic Cartilage Implant is a molded cylindrical implant designed for the treatment of first metatarsophalangeal (MTP) joint osteoarthritis, commonly affecting the big toe joint. We sometimes say it looks like a gum drop, a popular candy from our childhood. Composed of an organic hydrogel polymer made of polyvinyl alcohol and saline, the Cartiva Toe Implant mimics the mechanical properties of natural cartilage. Its purpose is to replace damaged cartilage, reduce pain, and maintain range of motion.

Cartiva comes in multiple sizes (6mm, 8mm, 10mm, and 12mm) and is implanted through a press-fit procedure in the metatarsal head of the MTP joint. Since its FDA approval in 2016, Cartiva SCI has been marketed as a less invasive alternative to traditional fusion surgeries for MTP joint osteoarthritis.

We provide a history of Cartiva on our main page here, check it out.

Cartiva Toe Implant Lawsuit

Why Did Stryker Recall the Cartiva Toe Implant?

Stryker’s recent safety notice cites post-market data and published studies showing that patients with the Cartiva Toe Implant have experienced complications at rates higher than those reported during premarket and post-approval studies. In plain speak, it failed more than expected. These complications include:

• Implant revision or removal, often requiring additional surgeries.
• Implant subsidence (sinking into the bone).
• Displacement of the implant from its intended position.
• Persistent or worsening pain at the implant site.
• Nerve damage.
• Fragmentation of the implant material.

These issues led to the recall of all Cartiva SCI devices in the U.S. The affected product catalog numbers include CAR-06-US, CAR-08-US, CAR-10-US, and CAR-12-US, distributed between July 2016 and October 2024.

Implications for Cartiva Patients and Healthcare Providers

Bottom line, this is the end of Cartiva. This recall means that Cartiva toe implants are no longer available on the U.S. market. Per the notice, healthcare providers should remove the product from their inventory and cease use immediately.

Stryker directs hospitals and clinics:

1. Locate and quarantine all affected devices.
2. Return unused implants to the manufacturer.
3. Notify patients who have been treated with Cartiva SCI about potential risks and monitor them for complications.

For patients, this recall highlights the importance of ongoing medical follow-ups, particularly if you are experiencing new or worsening symptoms such as pain, stiffness, swelling, or difficulty walking.

What Should You Do If You Have a Cartiva Toe Implant?

Carvia patients experiencing pain need to call their doctors. If you have a Cartiva Toe implant, it’s essential to take proactive steps to protect your health. We cannot and do not give medical advice. So the first step is most important. 

1. Contact your doctor: If you are experiencing any symptoms, you can schedule an appointment with your doctor or healthcare provider. Your doctor can evaluate the Cartiva toe implant’s condition and recommend the appropriate course of action.
2. Monitor your symptoms: Be vigilant for signs of implant failure, such as pain, swelling, or reduced mobility. Report these symptoms promptly to your healthcare provider.
3. Consider legal options: If you’ve experienced complications or required additional surgeries due to a Cartiva implant, we will evaluate your case for free and see if you can obtain compensation for medical expenses, lost wages, and pain and suffering.

At KBA Attorneys, we understand the challenges that Cartiva patients face when dealing with defective medical devices. We have spoken with hundreds of Cartiva patients. We have seen their photos, reviewed their x-rays, and learned their stories. Our team is here to provide the guidance and support you need to pursue justice.

How KBA Attorneys Can Help with Cartiva 

KBA Attorneys has a long history of advocating for victims of defective medical devices, including those impacted by the Cartiva Synthetic Cartilage Implant. From the outset of the Cartiva case, we engaged medical experts to understand the science and medicine involved. We dug deep into what the long-term consequences are.

Having served hundreds of clients, we understand what the experience has been for patients who had the Cartiva toe implant. We appreciate the individual experience each has had as we have worked up every single one of our client’s cases personally, individually, and with due care. 

We have written extensively about Cartiva-related issues, helping patients and their families understand the risks and legal implications of this device. Here are some of our most recent blog postings about Cartiva toe implants. 

Cartiva Implant Lawsuit: What You Need to Know

Metatarsal Phalangeal Joint Replacement and Cartiva Implant Lawsuits

The Biggest Failures of Cartiva Toe Implants 

Problems with Cartiva Toe Implants

Big Toe Joint Replacement: What You Need to Know

Our dedicated team of attorneys have extensive experience in medical device litigation and has the expertise to handle complex cases involving:

• Defective product design
• Failure to warn about known risks
• Post-market surveillance failures

We have been here and will continue to be here for Cartiva toe implant patients. We take the time to hear your story, analyze the facts and the law, and present a compelling case on your behalf.

Other Firms Send Their Cases to KBA Attorneys because We Are the Best Cartiva Toe Implant Attorneys – Contact Us to See Why

Many firms advertise for cases like the Cartiva toe implant matter. We are blessed with long-standing relationships with the largest firms across the country and the biggest advertisers. Other law firms send their clients to KBA because we care about our clients, we have the experience and expertise to maximize recovery for our clients, and we have handled complex cases like this before. We are responsive and we advocate, like true professionals.

At KBA Attorneys, we are here to help you navigate this challenging time. If you have questions about the Cartiva recall or need legal assistance, contact us today for a free consultation. Together, we can work toward holding manufacturers accountable and securing the compensation you deserve.