Cartiva Implant Lawsuit

Have you been dealing with persistent pain, swelling, or even the need for additional surgeries after receiving a Cartiva implant for your big toe arthritis? You're not alone. Many patients across the country are coming forward with similar stories, reporting that their implants have failed to relieve their symptoms as promised.

Many have experienced worsening conditions, leading to further medical issues. People are now taking legal action against the manufacturer as concerns about the safety and effectiveness of these implants grow.

For nearly a decade, Osborne, Francis & Pettis have been fighting for patients who have been betrayed by defective medical devices. We have won billions for our clients, including $1 billion against Stryker before, the company behind the Cartiva Implant.

If your Cartiva implant has failed you, get in touch with us online or call (561) 293-2600 today to find out if you qualify for a Cartiva lawsuit.

“I recently had the experience of working with Osborne, Francis & Pettis Law Firm after being involved in an accident, and I can't recommend them highly enough. This was my first time needing legal assistance, and they made me feel like a priority from the very beginning. Their knowledge and expertise were evident, but what really stood out to me was their genuine commitment to putting my needs first.”

- Client: Brandi G.

What Is the Cartiva Toe Implant?

The Cartiva implant is a medical device intended for the big toe to help relieve patients suffering from big toe arthritis. This condition causes pain and stiffness in the joint located at the base of the big toe. However, over time, wear and tear slowly damage the joint, leading to pain and even problems walking or maintaining balance.

Therefore, the implant is meant to help people walk more comfortably and get back to their daily activities without the pain that comes from damaged cartilage.

It is a specially molded implant only about the size of a pea that serves as a replacement for the degraded cartilage in the big toe. The implant is created from a material called polyvinyl hydrogel (PVA hydrogel), which is widely used in many medical devices because it has good compatibility with the body, strong durability, low friction, and the right amount of water content.

Before the Cartiva implant, the only way to treat big toe arthritis was through a difficult fusion surgery where the bones in the toe joint are surgically fused together to prevent friction.

To put in the Cartiva, special tools are used to create a space in the metatarsal joint, located in the foot, where the implant will be placed.

Cartiva Implant Problems

Many people turned to the Cartiva big toe implant, hoping for relief from their painful arthritis, only to find their expectations shattered by a host of unexpected complications and injuries.

One major issue that has plagued patients is that the implant can unexpectedly shrink after being placed into the toe. This shrinkage causes the implant to become loose and move out of its original position. When this happens, it can cause unbearable pain and even nerve damage, further limiting patients’ mobility and even requiring revision surgery.

In addition to shrinkage, patients have reported other complications. Some have experienced:

• Infections.
• Implant fractures.
• Osteolysis, where the bone around the implant starts to break down.
• Painful cysts.
• Silastic granulomas, painful lumps that can form around an implant, caused by the body’s reaction to foreign materials.

All of these issues can significantly affect a person’s quality of life, often requiring additional surgeries, like removing the Cartiva implant or performing a procedure to fuse the bones together.

Unfortunately, these problems are due to the PVA hydrogel. While this material is designed to be safe for the body, in many cases, it doesn’t hold up well over time. Instead of staying strong, the PVA can break down quickly after it’s implanted, leading to the shrinkage and complications we’ve mentioned.

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Cartiva Implant Failure Rate

Quickly after its introduction in 2016, reports began to reveal higher-than-expected failure rates and complications linked to the Cartiva implant.

A review of the Manufacturer and User Facility Device Experience database from July 2016 to June 2023 showed concerning results. Out of 236 reports, a staggering 55% cited unspecified device problems, and 56% reported issues like pain and inflammation.

Alarmingly, nearly 74% of patients required removal of the implant, with an additional 9% still pending removal. Among those who had revision surgeries, about 68% ended up needing a more invasive procedure called fusion.

Furthermore, the warning label for the Cartiva implant states that it only has a failure rate of 13.5%. However, some studies have reported failure rates as high as 64%.

Getting an implanted medical device is supposed to be a big leap toward relief from constant pain and a return to a normal life. But for too many Cartiva patients, that hope has been replaced with allegedly even worse complications, including severe pain, infections, and the need for revision surgery.

The FDA has reportedly received 144 adverse events involving the Cartiva implant since it was first approved. If you’ve been affected, contact the experienced medical device lawyers at Osborne, Francis & Pettis online or call (561) 293-2600 today.

About the Cartiva Implant Lawsuit

Many people are now filing lawsuits against Stryker, the global medical device company behind the device, for Cartiva implant problems.

These lawsuits argue that Stryker did not fully and accurately disclose to the FDA or the public the abnormally high rates of Cartiva implant failure. Legal claims state that had the FDA been aware of the complications with the implant, it may not have given it such a quick approval, instead opting for a more rigorous look into the implant’s safety.

Despite the growing number of reports of Cartiva implants and more studies finding a higher failure rate than described on the label, Stryker has not updated its warning label and has not recalled the implant.

Steps in Filing a Cartiva Lawsuit

If you have suffered complications from a Cartiva toe implant, you may be eligible for legal action. However, some people are understandably nervous about filing a lawsuit. You may be unfamiliar with the legal process or worried about the time involved.

At Osborne, Francis & Pettis, we are here to address any concerns you may have and put your mind at ease. Below is what you can expect during a Cartiva implant failure lawsuit.

A 100% Free Consultation of Your Potential Claim

You can schedule a 100% free legal case review where our team can take a closer look at your situation. We will check if you qualify based on factors like what injuries you experienced, your medical records, and when you received your implant.

Filing a Medical Product Liability Case

If we determine that you have a solid case, we can move forward with a medical product liability claim against Stryker, the manufacturer of the Cartiva implant. These types of lawsuits hold medical device manufacturers responsible for flaws in the design or the manufacturing of the product or for not warning you about possible risks related to the implant.

Our team will prepare a legal document called a complaint. This document starts the legal process and outlines exactly what you’re asking for in terms of compensation and why.

Negotiations or Trial

There is no guaranteed outcome for any case, as each specific situation is unique and depends on several factors. However, here are a few possibilities:

• Financial Support Available in a Settlement: If successful, you could potentially get money for medical bills, lost wages, pain and suffering, and other issues caused by your complications. Your lawyer will work hard to get you a fair deal through a settlement with the company by negotiating on your behalf.
• Fight for You in Court: If a settlement can’t be reached, your case may go to trial. There, our lawyers will defend your rights in an attempt to get accurate compensation to address what you’ve been through.

Medical device cases can be very complicated, so it’s helpful to have an attorney experienced in these claims to give your case a better chance of success. Studies have found that legal cases tend to be stronger when you get a lawyer involved. For example, a 2016 Martindale-Nolo study found that people with a lawyer received an average compensation of $77,600, whereas those who were self-represented averaged only $17,600.

“We have successfully taken on Stryker in the past, winning over $1 billion for people wrongfully harmed by defective hip implants. Now, we are ready to challenge them again on behalf of those reportedly injured by the Cartiva toe implant. Our history with this company gives us the knowledge and determination needed to support those affected.”

- Attorney and Founder Joseph Osborne