Cartiva Implant Lawsuits Bolstered by New Study Finding Higher Revision and Failure Rates

The findings of a new study suggests that the rate of reoperation associated with Cartiva implants may be 30 times higher than what is seen with alternative procedures, which may provide important evidence in lawsuits now being pursued against the manufacturer by individuals who received the synthetic cartilage implant (SCI).

The Cartiva toe implant is a cylindrical device made from polyvinyl alcohol-based hydrogel (PVA) that has been marketed as a revolutionary alternative to fusion surgery for treating hallux limitus or hallux rigidus, which are forms of degenerative arthritis in the big toe’s first joint.

However, a number of Cartiva implant lawsuits are now being pursued by individuals who experienced painful and debilitating complications when the device failed, alleging that the manufacturers did not adequately disclose the failure rate associated with the device.

In a study published in the October 2024 issue of the medical journal Foot and Ankle Surgery, researchers confirmed that they were unable to find evidence that patients had any better results with the Cartiva SCI, and higher rates of further surgical intervention among individuals who received the toe implant led the researchers to recommend standard joint fusion surgery as the preferred surgical option for hallux rigidus.

While the Cartiva implant was approved by the FDA based on clinical trials that showed only a 13% failure rate, concerns have emerged in recent years about alarming Cartiva implant failure rates, which have caused some users to experience severe toe pain, loosening of the implant and other problems, often resulting in the need for additional surgeries.

Lawsuits filed to date have pointed to prior case reports and medical studies, which have outlined how many patients’ conditions have worsened significantly after the Cartiva implant failed. This is often attributed to the removal of bone during the procedure, which typically results in considerably shortened big toes, potentially leading to further foot injuries due to altered weight distribution.

The manufacturers, Cartiva Inc., Wright Medical Group N.V. and Stryker B.V., now face product liability claims alleging that they sold a defective and unreasonably dangerous implant, and this new study is likely to add to the evidence plaintiffs are presenting in the litigation.

Cartiva Implant Failure Risks

This new study was led by Thomas L. Lewis of the King’s College Hospital NHHS Foundation Trust, in London, aiming to evaluate the clinical outcomes of using Cartiva Synthetic Cartilage Implant (SCI) compared to arthrodesis (joint fusion) in patients suffering from hallux rigidus.

The team of reseachers monitored 33 patients who underwent either the Cartiva SCI procedure or joint fusion surgery, and tracked patient-reported outcome measures (PROM) over an average follow-up period of 2.3 years.

According to the findings, patients who received a Cartiva implant had a 29.4% reoperation rate, compared to the arthrodesis group’s reoperation rate of 0%, indicating a potential issue with the durability or effectiveness of the Cartiva implant.

The study concluded that Cartiva SCI does not outperform arthrodesis in patient-reported outcomes, and due to the higher need for follow-up surgeries with Cartiva, arthrodesis was recommended as the better option for treating hallux rigidus.

“This retrospective comparative study found no significant superiority of Cartiva SCI over arthrodesis in terms of PROMs. Due to the higher rate of further surgical intervention in the SCI cohort, we recommend arthrodesis as the preferred surgical option for hallux rigidus”, said Lewis and colleagues.

Cartiva Lawsuits Over Implant Failures

In several Cartiva lawsuits filed as of November 2024, individuals have raised allegations against Cartiva Inc., Wright Medical Group and Stryker, claiming the manufacturers have withheld information for years about the increasing number of Cartiva implant failures, in an attempt to avoid a Cartiva recall and increase profits.

Cartiva implant lawsuits have cited several studies and case reports conducted in recent years, which have not been able to duplicate the minimal failure rates reported by the manufacturer during clinical trials.

Rather, lawsuits point to recent medical research and real-world data findings that suggest 79% of Cartiva implants fail within two years, and that 43% of patients reported the Cartiva implant offered no benefit in relieving toe pain or increasing mobility within the 19 month follow-up.

Cartiva Implant Failure Lawyers

As scientific and medical research continues to surface that confirms the increased Cartiva failure risks, lawyers are providing free consultations and claim evaluations for individuals across the U.S., to help determine if they may be eligible to pursue a lawsuit over their Cartiva implant failure.

Lawsuits against Cartiva’s manufacturers claim that design defects make the toe implant prone to fail and cause severe pain, often resulting in the need for additional surgery and leaving patients with long-term disability that could have been avoided if alternative surgical options had been pursued to treat their initial hallux rigidus.

Financial compensation may be available through a Cartiva implant failure lawsuit settlement for individuals who received the big toe implant and experienced any of the following complications:

• Implant Failure/Fracture
• Subsidence (implant sinks into the bone)
• Toe Fusion Surgery
• Replacement Surgery
• Revision Surgery

All claims are being pursued by Cartiva implant lawyers on a contingency fee basis, which means that there are no fees or expenses paid unless a Cartiva settlement or lawsuit payout is received.