Pullano & Siporin has taken a leading role in representing victims of the defective Cartiva implant device. We are believed to be the only law firm in Illinois actively litigating cases against Cartiva, and represent many more Cariva victims from all across the country.
If someone you know has been diagnosed with arthritis in their foot, or conditions like hallux rigidus or hallux limitus, and had a Cartiva device implanted in their foot, please contact our team at Pullano & Siporin for more information.
Cartiva Failures Lead to AVITRAC™ MTP Revision System
The Cartiva toe implant device was approved by the FDA in 2016. By 2019, the Cartiva device had already failed so many patients that one company designed a product specifically to address failed Cartiva implants naming it after the device, spelled backwards. The AVITRAC™ MTP Revision System is a groundbreaking option for patients requiring revision surgery after a failed Cartiva implant.
Designed by Paragon 28, this system promises a unique approach to resolving issues caused by previous procedures while prioritizing patient outcomes and surgical efficiency. If you or a loved one has experienced complications from a Cartiva implant or any medical procedure, it is essential to understand the options available for treatment, the role of informed consent, and how legal recourse might be necessary if negligence is involved.
What is the AVITRAC™ MTP Revision System?
The AVITRAC™ MTP Revision System, recently launched by Paragon 28, is specifically engineered for patients requiring revision surgery due to complications from a failed Cartiva implant. The first MTP joint, located at the base of the big toe, plays a crucial role in mobility and weight-bearing.
From 2016-2024, Cartiva implants were a popular treatment option among podiatrists for conditions like arthritis, hallux rigidus, or hallux limitus. However, these Cartiva implant devices proved to have a high rate of failure, leaving patients with ongoing pain, limited mobility, and the need for corrective surgery.
As stated by the manufacturer, the AVITRAC™ system stands out for several reasons:
- Innovative Design — The system includes an anatomically designed dorsal plate with integrated polyethylene pegs. These components provide a secure foundation for fixation, reducing the risk of further complications.
- Streamlined Procedure — With a single-tray delivery, the system offers a more efficient surgical process. This design reduces operating room time and simplifies the revision procedure.
- Addressing Complications — Failed Cartiva implants often leave significant bone loss in the first MTP joint. The AVITRAC™ system uses the dorsal plate’s polyethylene pegs to fill the void left behind, offering stability and improving patient outcomes.
- Focus on Patient Recovery — By addressing the specific challenges of failed Cartiva implants, the AVITRAC™ system aims to reduce recovery times and improve long-term joint functionality for patients.
Why Do Cartiva Synthetic Cartilage Implants Fail?
Cartiva implants are designed to relieve pain and improve joint function. However, 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.
When Cartiva implants fail, patients often face prolonged pain, limited mobility, and the prospect of additional surgical interventions. The AVITRAC™ system was designed to address these challenges and provide a more effective solution for patients requiring revision surgery.
The Importance of Informed Consent in Medical Procedures
Patients must provide informed consent before undergoing any medical procedure, including the placement of a Cartiva implant. This legal and ethical principle requires healthcare providers to fully inform patients of a procedure’s risks, benefits, and alternatives.
This Informed consent is critical for several reasons:
- Patient Autonomy — Patients have the right to make informed decisions about their healthcare based on a clear understanding of the procedure and its potential outcomes.
- Transparency — Providing detailed information ensures that patients are aware of potential risks, such as implant failure or the need for future revision surgeries.
- Accountability — Informed consent helps establish a standard of care, ensuring that medical professionals act in the patient’s best interests.
Unfortunately, failures in informed consent can occur. If a healthcare provider fails to adequately explain the risks of a procedure or omits critical information, patients may be left unprepared for complications.
Medical Malpractice and Cartiva Implants
If a Cartiva implant fails and the complications are due to negligence – whether in the placement of the implant, the surgical procedure, or a lack of informed consent – it may constitute medical malpractice.
Examples of negligence in these cases can include:
- Failure to Inform Patient of Risks, Cartiva Failure Rates — Surgeons must carefully assess whether a patient is a suitable candidate for an implant and disclose all associated risks, including the medical literature revealing Cartiva’s high failure rates.
- Improper Implant Placement — Errors during surgery can lead to implant instability, pain, and the need for revision.
- Post-Surgical Negligence — Inadequate follow-up care or failure to address complications promptly can exacerbate the patient’s condition.
Patients experiencing complications from a failed Cartiva implant may face not only physical pain but also emotional and financial burdens. If negligence is suspected, legal action may be necessary to secure compensation for medical expenses, lost wages, and pain and suffering.
Advocating for Patient Safety
The introduction of the AVITRAC™ MTP Revision System offers hope for patients dealing with the challenges of a failed Cartiva implant. However, this innovation also highlights the importance of patient safety and accountability within the healthcare system.
As medical technology advances, so must the commitment to informed consent and ethical care. Patients deserve to be fully informed about their options and protected from negligence at every step of their healthcare journey.
At Pullano & Siporin, we are proud to stand by those who have been wronged, helping them navigate the legal system and secure the justice they deserve. We have a proven track record of representing clients in medical malpractice cases. With over 50 years of combined experience, our personal injury attorneys are dedicated to holding healthcare providers accountable and helping patients achieve justice in Chicago and Illinois.
If you or a loved one has experienced complications from a Cartiva implant or any medical procedure, contact us today for a free consultation. Together, we will work to hold those responsible accountable and secure the justice you deserve.
