Cartiva Implant Lawsuit Filed Over Bone Loss and Deformity of Big Toe, Resulting in Fusion Surgery

A Pennsylvania woman has filed a lawsuit against manufacturers of the Cartiva toe implant, indicating that the device failed and caused her to experience painful deformity and bone loss in her big toe, which resulted in the need for an additional fusion surgery.

The complaint (PDF) was filled by Kelly M. Peachey in the U.S. District Court for the Western District of Pennsylvania on August 8, presenting claims against Cartiva, Inc., Wright Medical Group and Stryker B.V. as defendants.

The Cartiva SCI is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted as a revolutionary toe implant since it was introduced. However, within a few years concerns have emerged about alarming toe implant failure rates, which have caused patients to experience widespread complications, including reports of severe toe pain, loosening, fracture and other problems, often resulting in the need for a surgery to fuse the big toe. As a result, the manufacturers now face a growing number Cartiva implant lawsuits over failure to disclose known risks associated with the device.

Cartiva implants have been sold as a revolutionary new treatment option for arthritis that has caused cartilage in the big toe joint to degrade, known as hallux limitus or hallus rigidus, which impacts about 2.2 million people in the U.S., and results in severe pain.

The synthetic cartilage implant is designed to provide cushioning to replace the degraded cartilage and provide pain relief, and is considered an alternative to fusing the joint, a procedure known as arthrodesis, which has a longer healing time and is a more complicated surgical procedure.

Cartiva Implant Failure Led to Big Toe Fusion

According to the lawsuit, Peachey was given a Cartiva implant in December 2019, due to arthritis in her right big toe. After receiving the implant, Peachey indicates she suffered serious dysfunction, swelling and severe pain caused by the Cartiva device.

In August 2021, doctors told Peachey, a firefighter and emergency medical technician, that the toe implant had failed. A month later, they surgically removed the device and had to fuse the bones in Peachey’s right big toe, significantly limiting its flexibility and use. She also suffered bone loss and permanent big toe deformity due to the implant removal, the lawsuit notes.

Peachey’s doctors told her she suffered arthritis progression, implant failure and indicated her body may have had a reaction to the implant. The lawsuit indicates she will likely have to undergo another fusion surgery.

“As a result, and due to the Defective Product, Plaintiff will require at least one more surgery to help correct the ongoing defect,” the lawsuit states. “The Cartiva implant surgical procedure was not effective at alleviating pain or restoring range of motion.”

2023 Cartiva Implant Lawsuit Updates

Peachey’s complaint joins a number of other similar lawsuits over Cartiva implants filed in recent months, each raising similar allegations of fact and law, claiming that the product fails due to design defects.

Although the manufacturer suggested the Cartiva failure rates were low, the lawsuits point to a study published in November 2020, which found that as many as 64% of individuals who received a Cartiva implant for hallux rigidus experienced failure within four weeks of surgery, and the failure rate increased to 79% after 19 months.

Some reports also suggest that Cartiva failures have left individuals in a much worse position, due to the amount of bone removed during the toe implant surgery. In this scenario, patients have been left with significantly shorted big toes, which can lead to additional foot injuries from the offloading effect.

Such poor patient outcomes will likely result in many more implant recipients seeking settlements or compensation from the manufacturer through the filing of a Cartiva lawsuit, alleging that the manufacturer did not uphold their duty to adequately investigate that the devices were safe and failed to warn patients about the increased risk of implant failure.