Cartiva Toe Implant Recall Issued by Stryker: What You Need to Know

Pullano & Siporin Believed to be First Firm in Illinois to File Cartiva Lawsuit

Not all law firms are equipped to handle the complex nature of medical device defect litigation. Pullano & Siporin is believed to be the first law firm actively litigating these cases in Illinois, and we have retained all the necessary experts to do so successfully.  As a result, we are the only law firm in Illinois with the expertise, dedication, and resources to advocate for those affected by Cartiva implant complications – ensuring you get the justice and support you deserve.

The Cartiva Synthetic Cartilage Implant (SCI) was designed as an innovative solution for patients suffering from osteoarthritis in the first metatarsophalangeal (MTP) joint, commonly known as the big toe joint.

Made from a hydrogel polymer that mimics natural cartilage, the implant aims to alleviate pain, restore mobility, and improve the quality of life for patients. Promoted as a less invasive alternative to traditional joint fusion surgery, the Cartiva implant promises to shorten recovery times while preserving joint flexibility considerably.

However, a recent recall issued by Stryker, the manufacturer of the device, has raised serious concerns. Reports of higher-than-expected failure rates have surfaced, prompting the manufacturer to address these issues immediately.

This article explores the recall, its implications, and what steps patients and providers should take moving forward.

 

What Is the Cartiva Synthetic Cartilage Implant?

The Cartiva Synthetic Cartilage Implant (SCI) is a medical device specifically designed to treat osteoarthritis in the first metatarsophalangeal (MTP) joint, commonly known as the big toe joint. Osteoarthritis in this area often leads to significant pain, stiffness, and reduced mobility, making daily activities such as walking and exercising extremely challenging. 

The Cartiva implant was developed and approved by the FDA in 2016 as a cutting-edge solution to alleviate these symptoms while preserving joint movement.

 

A Hydrogel Solution for Joint Pain

The Cartiva Synthetic Cartilage Implant is composed of a unique hydrogel polymer made from polyvinyl alcohol and saline, mimicking the properties of natural cartilage. Its high water content allows it to replicate the elastic and compressive mechanical properties of healthy cartilage, providing cushioning and support for the joint.

Unlike traditional surgical options such as joint fusion, which eliminates motion in the joint, the Cartiva implant was designed to maintain a natural range of motion in the toe while reducing pain. However, recent concerns over the implant’s long-term performance and safety have led to heightened scrutiny, resulting in the recent recall of the device.

 

Why Was the Cartiva Toe Implant Recalled?

On October 31, 2024, Stryker urgently recalled the Cartiva Synthetic Cartilage Implant after reports of a series of adverse outcomes experienced by patients. These include:

  • High Rates of Revision and Removal — Many patients required follow-up surgeries to remove or replace the implant due to its failure to alleviate symptoms or maintain functionality.
  • Implant Subsidence and Displacement — Instances where the implant sank deeper into the bone or shifted from its intended position, resulting in loss of effectiveness and additional complications.
  • Chronic Pain and Nerve Damage — Patients reported persistent or worsening pain and, in some cases, nerve injuries linked to the implant.
  • Fragmentation — The implant’s material broke apart in some cases, leading to additional damage to the joint.

 

Postmarket vs. Clinical Trial Data

During the initial approval process in 2016, clinical trial data suggested the Cartiva implant was a reliable and effective alternative to traditional joint fusion, with only a 13% failure rate reported. 

However, postmarket reports and real-world data have painted a starkly different picture, revealing significantly higher failure rates than anticipated and undermining confidence in the implant’s long-term efficacy and safety.

 

Alarming Failure Rates and Limited Patient Benefits 

Researchers from the UK have found that nearly half of all Cartiva toe implant patients suffered complications, and nearly 20% required reoperations or revision surgery. These findings, published in the medical journal Cureus on November 19, raised serious concerns about the device’s performance.

Further medical research and real-world data suggest that the situation may be much worse. Studies indicate that 79% of Cartiva implants fail within two years, and 43% of patients reported no improvement in toe pain relief or mobility during a 19-month follow-up period. 

These findings have fueled numerous lawsuits against Cartiva’s manufacturers, with allegations that the company failed to adequately address or disclose the device’s risks.

 

Potential Risks for Patients

The troubling data surrounding the Cartiva Synthetic Cartilage Implant (SCI) recall underscores several significant risks that patients may face and should be aware of. These include:

  • Persistent or Worsening Pain A key concern for many patients is persistent pain following the procedure. For some, the implant fails to alleviate symptoms, and in others, the pain worsens, signaling potential implant failure or associated complications.
  •  Difficulty Walking and Joint Stiffness Despite its design to preserve joint mobility, the Cartiva implant has been linked to cases of joint stiffness and difficulty walking. These issues can stem from implant subsidence, displacement, or damage, significantly impacting a patient’s ability to perform everyday tasks.
  • Nerve Damage or Skin Reactions Nerve damage, resulting in numbness, tingling, or sharp pain, has also been reported among some patients. Additionally, adverse skin reactions near the surgical site have also emerged as another potential risk.
  • Weakness or Swelling in the Big Toe Joint Weakness or persistent swelling in the affected joint can further hinder mobility and overall joint function, often requiring additional medical intervention.

 

What Actions Are Being Taken?

In response to the significant failure rates of the Cartiva Synthetic Cartilage Implant (SCI), Stryker has issued detailed instructions to healthcare providers to address the recall and mitigate risks for affected patients. These include:

  • Identifying and Quarantining Affected Devices Healthcare providers are instructed to locate Cartiva SCI devices in their inventory and immediately isolate them to prevent future use.
  • Returning Devices to the Specified Address Affected devices must be returned to Stryker at the provided address, with proper documentation included. Providers are encouraged to track their returns to ensure they are processed.
  • Informing Patients of Potential Risks Providers are expected to proactively communicate with patients who have received the Cartiva implant, discussing the potential risks. Providers should also outline alternative treatment options and monitor patients for new or worsening symptoms.
  • Notifying Downstream Distributors and Affected Parties If healthcare facilities have distributed the affected devices to other organizations, they are required to notify those parties and provide details about the recall. This ensures that all impacted devices are accounted for and removed from circulation.
  • Reporting Adverse Events Providers are encouraged to report any adverse events related to the Cartiva implant to Stryker and the FDA. This ongoing feedback helps refine postmarket surveillance efforts and ensures all risks are thoroughly documented.

 

The Cartiva implant recall serves as a critical reminder of the challenges in balancing innovation with safety in medical device manufacturing. These findings highlight the importance of rigorous and ongoing surveillance of medical devices after they are introduced to the market to protect patient outcomes and maintain trust in new technologies.

 

What Should Patients Do?

If you have received the Cartiva implant, do not wait for symptoms to worsen. Take an active role in your healthcare by consulting with your provider, exploring treatment alternatives, and staying informed about your condition. Early intervention and regular monitoring are key to managing risks and maintaining quality of life.

Contact Pullano & Siporin: Chicago’s Trusted Personal Injury Lawyers

If you or a loved one has been affected by complications from the Cartiva Synthetic Cartilage Implant, our experienced team at Pullano & Siporin is here to help. With over 50 years of combined experience in personal injury law, we provide exceptional legal expertise and a strategic approach tailored to each individual case.

Renowned for our compassionate advocacy and proven track record of success, we have helped countless clients in Chicago and Illinois secure justice and the compensation they deserve. Don’t navigate this journey alone. Take the first step toward protecting your rights.

Contact us today for a consultation. Let us fight for you and ensure your voice is heard.

Latest Post

Send Us A Message