The FDA has classified a recall involving the Cartiva Synthetic Cartilage Implant (SCI), a defective medical device used to treat arthritis in the big toe joint. The recall affects all devices distributed between July 2016 and October 2024, following multiple reports of complications with the device. Complaints include implant subsidence, displacement, pain, nerve damage, fragmentation, and the need for revision surgery. The FDA identified device design as the cause of the recall.
The Cartiva Synthetic Cartilage Implant was presented as a treatment option for people with arthritis in their big toe joint. This implant was offered as an alternative to toe fusion surgery, which would eliminate movement in the big toe joint. With the implant, patients were told they could maintain mobility while also addressing their arthritis-related pain.
The implant was approved by the FDA in 2016 and was used in patients across the United States and around the world. However, as more patients underwent the procedure, reports of complications began to emerge.
Why Was The Cartiva Implant Recalled?
According to the FDA recall notice, patients with the implant may experience a higher-than-expected occurrence of revision surgery, implant removal, implant subsidence, displacement, pain, nerve damage, and fragmentation. In 2024, the FDA identified the device’s design as the cause of the symptoms and issued a Class II recall.
As part of the recall, healthcare providers are to continue monitoring patients for new or worsening symptoms, including pain, difficulty walking, stiffness, swelling, weakness in the big toe joint, and other signs that may indicate complications with the implant.
Common Complications Associated With the Cartiva Implant
According to the FDA recall notice and reports from patients, complications associated with the Cartiva implant may include:
- Implant subsidence, where the implant sinks into surrounding bone
- Implant displacement or migration from its intended position
- Persistent or worsening pain
- Nerve damage
- Swelling and inflammation
- Reduced mobility or difficulty walking
- Fragmentation of implant material
- Revision surgery
- Implant removal
- Toe fusion surgery following implant failure
The need for additional procedures is a major concern for many patients, as the device was marketed as an alternative to fusion surgery. However, some patients reportedly required fusion procedures after experiencing complications or implant failure.
As reports of these complications increased, patients across the country began filing lawsuits against Cartiva, Wright Medical Group, and Stryker. Many of those cases have been consolidated in MDL No. 3172 in the United States District Court for the Eastern District of Arkansas. Plaintiffs allege that the companies failed to adequately warn patients and physicians about the risks associated with the device. The defendants deny wrongdoing, and the litigation remains ongoing.
What Patients Should Know After The Recall
Patients who have received a Cartiva implant should not change their treatment plan without first consulting their healthcare provider. However, those experiencing ongoing pain, difficulty walking, swelling, stiffness, weakness in the big toe joint, or other worsening symptoms may wish to discuss those issues with their doctor. The FDA specifically advised healthcare providers to continue monitoring patients for these types of complications following the recall.
Patients who have undergone revision surgery, implant removal, or toe fusion surgery after receiving a Cartiva implant may also want to keep copies of their medical records and treatment history. Those records can play an important role in understanding whether their complications are related to the recalled device.
How Goldenberg Lauricella Is Helping Patients Affected By Cartiva Implant Failures
At Goldenberg Lauricella, PLLC, we have spent decades helping individuals and families pursue claims involving defective products and serious injuries. Our personal injury attorneys are investigating claims involving the Cartiva Synthetic Cartilage Implant and the complications associated with the recalled device.
Individuals who experience implant failure, revision surgery, chronic pain, nerve damage, or other complications after receiving a Cartiva implant may have legal options available depending on their circumstances. Our team is reviewing cases and helping affected patients understand their rights as the Cartiva litigation continues.
If you believe you may have been affected by a recalled Cartiva implant, contact Goldenberg Lauricella for a free consultation to learn more about your potential legal options.