Background on the Cartiva Implant

The Cartiva Synthetic Cartilage Implant (SCI) was designed as a groundbreaking solution for individuals with arthritis in the big toe joint. Marketed as a durable and minimally invasive alternative to joint fusion, the Cartiva implant promised pain relief and improved mobility. However, reports from patients and surgeons suggest that the device may not perform as intended, leading to an FDA recall and lawsuits.

The Cartiva SCI was approved by the FDA in 2016. The implant is made of a hydrogel material designed to mimic natural cartilage and cushion the big toe joint. Unlike traditional joint fusion surgery, which limits motion, the Cartiva implant was intended to maintain mobility while alleviating pain.

Alleged Injuries and Complications

Despite its intended benefits, studies have shown a much higher failure rate than initially reported by its manufacturer. Patients report complications following Cartiva implantation, including:

• Implant Failure – Premature breakdown of the implant, requiring removal and revision surgery.
• Persistent or Worsened Pain – Ongoing or increased pain after surgery.
• Implant Displacement – The implant moves from its intended position, reducing its effectiveness.
• Need for Revision Surgery – Due to implant failure, many patients undergo painful and costly corrective surgeries, sometimes leading to joint fusion—the procedure the Cartiva implant was designed to avoid.

With some studies showing a 79% failure rate, the FDA had little choice but is issue a federal recall of all Cartiva Synthetic Cartilage Implants manufactured from 2016 to the present.  If you or a loved one has been injured by the Cartiva SCI, please contact Wilentz, Goldman & Spitzer, P.A. immediately for a free consultation.

The Current Status of Litigation

Lawsuits are being filed by patients who allege that the Cartiva implant was defectively designed, inadequately tested and that the manufacturer failed to warn patients and surgeons about the risks. Some of the key legal claims in these cases include:

• Defective Design – Plaintiffs argue that the Cartiva implant was inherently flawed, leading to a high failure rate.
• Failure to Warn – Lawsuits claim that the manufacturer did not adequately disclose the risks associated with the implant, including potential failures and the need for additional surgeries.
• Negligence – Some claims allege that the manufacturer did not conduct sufficient testing before bringing the device to market.

Many cases are now proceeding in state and federal courts. It remains to be seen whether individual lawsuits will be consolidated into a multi-district litigation (MDL) or class action lawsuit.

What Should Affected Patients Do?

Wilentz, Goldman & Spitzer, P.A. is actively investigating Cartiva implant cases and is committed to holding negligent medical device manufacturers accountable. Contact us today for a free consultation to discuss your legal rights.