Have You Suffered Complications From a Failed Cartiva Toe Implant? You May be Entitled to Compensation
Many patients trusted Cartiva implants to relieve their big toe arthritis pain, only to face devastating complications, additional surgeries, and ongoing suffering and issues with stiffness and mobility. If you received a Cartiva implant that failed or caused complications, you may have rights. The October 2024 recall confirms what many patients already knew -- these implants have an unacceptably high failure rate.
This article is all about the Cartiva toe implant lawsuit. Below, we will dig deeper into the details surrounding the Cartiva implant failure lawsuit and how it came about. We will discuss the Cartiva implant crisis and how you may be able to seek compensation for your medical bills, surgery, and rehabilitation.
Overview of the Cartiva Toe Implants
The Cartiva Synthetic Cartilage Implant (SCI) was initially marketed as a revolutionary solution for people suffering from big toe arthritis (hallux rigidus). The hope was that it would preserve joint mobility and reduce pain without a person having to undergo the traditional fusion surgery. However, in recent years, patients that received the Cartiva implant have started to experience a number of serious problems because the implant failed to function as intended.
If you received a Cartiva toe implant and are experiencing ongoing pain or other complications, you're not alone. Recent studies have revealed that Cartiva toe implant failures are shockingly common, and this has led to a growing number of lawsuits against the manufacturer. Hundreds of reports about the implant's failure have been filed, and it appears that many more are coming.
Please don't hesitate to call us at (321) LAWSUIT for a free consultation. We can help you find out if you qualify for the Cartiva toe implant lawsuit, and if you do, we can help guide you through the next steps toward getting compensation for what you've been through.
Who Qualifies for the Cartiva Toe Implant Lawsuit?
If you received a Cartiva toe implant and experienced complications such as severe pain, implant failure, mobility problems, or nerve issues, you may be entitled to compensation through a Cartiva implant lawsuit. The manufacturer, Stryker, is facing lawsuits from patients who suffered from premature implant failure, implant migration, bone deterioration, or needed additional surgeries. Those who received their implant after July 2016 and experienced these types of complications should explore their legal options.
A study from the American Orthopedic Foot and Ankle Society found that Cartiva implants had an alarmingly high failure rate. Moreover, the FDA has received hundreds of adverse event reports, and recent studies indicate failure rates significantly higher than what the manufacturer initially disclosed to the FDA. This might suggest some level of foul play or lack of oversight, but this cannot be ascertained at this time.
If you need help or just have some questions, please don't hesitate to call us at (321) LAWSUIT. We're happy to talk with you for free to help you determine if you qualify for a Cartiva lawsuit. We work on a contingency fee basis, which means we don't get paid unless you get paid. So, you can be sure that a call is risk free to you.
Common Signs of Cartiva Implant Failure
Noticing problems early can help patients get the help they need. Some recent studies have identified several common issues that people experience after Cartiva implant placement, including:
- Pain
- Swelling
- Inflammation
- Stiffness
- Loss of Motion
- Bone Erosion
- Joint Issues
- Infection
- Fracture
- Implant Failure
- Hypersensitivity
These problems can arise soon after implant placement, within 4 weeks. Most issues with the Cartiva implant tend to manifest within a couple of years.
Cartiva Implant Recall
On October 31, 2024, Stryker issued an urgent medical device recall for the Cartiva Synthetic Cartilage Implant (SCI). The specific recall has been assigned recall number Z-0598-2025 on the website for the U.S. Food and Drug Administration (FDA). The recall affects all Cartiva implants distributed from July 2016 to October 2024, encompassing the following products:
- CAR-06-US: Cartiva SCI 6mm
- CAR-08-US: Cartiva SCI 8mm
- CAR-10-US: Cartiva SCI 10mm
- CAR-12-US: Cartiva SCI 12mm
Product Description
The Cartiva SCI is a cylindrical implant made from an organic hydrogel polymer composed of polyvinyl alcohol and saline. The device was designed with a high water content and elastic properties similar to natural cartilage. It was intended to replace damaged cartilage in the first metatarsophalangeal (MTP) joint, with the goal of reducing pain while maintaining range of motion.
Reason for Recall
According to Stryker's notification, recently published data and post-market reports indicated patients were experiencing complications at a higher-than-expected rate compared to the data submitted in the 2016 PMA (Pre-Market Approval). These complications include:
- Evidence of significantly higher failure rates than initially reported
- Consistent patterns of complications across patient populations
- Growing number of revision surgeries
On the FDA's website for the Cartiva implant recall, the reason for recall is as follows:
"Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation."
Guidelines for Patients with Cartiva Implants
Following the October 2024 recall, Stryker (medical device company) has issued specific guidelines for healthcare providers to monitor patients who received Cartiva implants. If you have a Cartiva implant, your healthcare provider should be actively monitoring you for any new or worsening symptoms that could indicate implant complications.
The most important symptoms to watch for include pain that is new or getting worse, any difficulty with walking, and unexpected reactions in the skin around the implant site. You should also pay close attention to stiffness in the big toe joint, swelling that persists or gets worse, limited mobility, and any weakness you experience. These symptoms could indicate potential problems with your implant and the cartilage in the big toe.
According to Stryker's recall notice, your healthcare provider should be discussing all potential risks with you during your follow-up visits. Since the long-term effects of cartilage replacement are not fully known, it's crucial to maintain regular contact with your healthcare provider. They should be evaluating your individual medical status and discussing all available treatment options if you're experiencing complications.
If you notice any changes in how your toe feels or functions, don't wait to seek medical attention. Document any symptoms you experience, when they occur, and how they affect your daily activities. This information will be valuable for both your medical care, as well as any legal claims you may be able to pursue. Call us at (321) LAWSUIT for a free consultation, and we can talk more with you about your legal rights and options.
Legal Rights for Affected Patients
If you've experienced complications after receiving a Cartiva implant, you may be entitled to compensation through an injury claim. Lawsuits in this area, which is often called "medical device litigation" or "product liability," generally focus on the following questions:
- Whether the product was defectively designed;
- Whether the manufacturer failed to adequately warn about risks;
- Whether the actual failure rate of the product was significantly higher than disclosed; and
- Whether the company prioritized profits over patient safety.
There are often other nuances and concerns, depending on the specific product, but these are some of the more basic questions we would want to ask in the context of the Cartiva implant failures.
Potential Types of Compensation for Claimants
A successful claim against the manufacturer of the Cartiva implant may provide financial recovery for at least some of the hardships you've faced. Compensation could cover things like medical expenses, as well as some of the long-term costs directly related to your toe implant complications. For example, some of the recoverable damages in a case like this might include things like:
- Medical costs (revision surgeries, toe fusion surgeries, medical treatment, rehabilitation);
- Lost wages and reduced earning capacity;
- Pain and suffering as a result of the implant or removing the cartiva implant after it failed; and
- Medical equipment and mobility devices to deal with the complications.
Call us today at (321) LAWSUIT for a free consultation. We'll help you determine what compensation you may be entitled to.
Potential Deadlines for Filing a Claim
It's important to act promptly if you're considering legal action. The time limit for filing a lawsuit (statute of limitations) varies by state, and it may be based upon:
- The date you received your implant;
- The date you discovered or should have discovered the implant's problems; or
- The date of the recall (October 2024).
Again, each state has its own statute of limitations. However, as a reference, a case involving failed Cartiva implants was recently filed in West Virginia. The plaintiff received his implant in 2019, experienced failures requiring removal in 2023, and filed his lawsuit in early 2024. That case is now scheduled for trial in October 2025.
To protect your rights, don't wait to explore your legal options. Call us today at (321) LAWSUIT for a free consultation to discuss your case. By acting quickly, you may be able to avoid missing the deadline for filing your claim. However, once you miss this deadline, you will likely be precluded from seeking compensation.
Documented Failure Rates and Clinical Evidence
Recent studies have revealed alarming statistics about the Cartiva implant failure rate. Below are some of the more critical points from recent scientific studies.
Initial FDA Approval vs. Reality
According to data found in recent medical studies and in the information provided on the FDA's website:
- The original FDA approval was based on a reported 13.5% failure rate
- Subsequent studies found failure rates as high as 79% within two years of implantation
- A recent clinical study showed patients with Cartiva implants were 30 times more likely to require another operation compared to alternative procedures
Post-Market Surveillance Data
Analysis of the Manufacturer and User Facility Device Experience database from July 2016 to June 2023 revealed:
- 55% of reports cited unspecified device problems
- 56% reported pain and inflammation
- 74% of patients required implant removal
- 68% of revision surgeries resulted in fusion procedures
- The FDA received 144 adverse event reports since initial approval
Call Us for a FREE Legal Consultation
We're happy to help you however we can, so please don't hesitate to reach out to us. We offer free consultations to help you understand your rights and options. Also, we don't take any fee unless we recover money for you. In other words, we don't get paid unless you get paid.
Call us anytime at (321) LAWSUIT, that's (321) 529-7848. A member of our team will talk with you at no cost and help you determine if you qualify for compensation through a Cartiva implant lawsuit.
We have strong relationships with excellent firms and attorneys all over the country. If we can't help you, we will work to make a personal introduction for you so that you can get in touch with an attorney or law firm that you can trust and that we know shares our values. In other words, at the very least, we can help you cut through the noise and get you to the right people.
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This article is intended for informational purposes only and does not constitute medical or legal advice. Consult with qualified medical and legal professionals for guidance specific to your situation.
