Lawsuit Alleges Cartiva Implant Failed, Resulting In Another Surgery 5 years Later and Toe “Fusion”

The Cartiva big toe implant’s polyvinyl membrane construction is prone to shrinkage, loosening and deformation, the lawsuit claims.

A product liability lawsuit has been filed by a Texas woman who suffered severe loss of mobility and foot pain after a Cartiva implant failed, indicating that the device was supposed to address arthritis in her big toe, but instead resulted in the need for multiple surgeries, including a toe fusion.

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 emerged about alarming Cartiva 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, resulting in a loss of mobility.

As a result, the manufacturers now face a growing number of similar Cartiva implant lawsuits, each raising allegations that the device was defectively designed and contained known risks that were not disclosed to patients and doctors.

In a recent complaint (PDF) filed in the U.S. District Court for the Northern District of Texas on April 22, Cathy Coleman seeks financial compensation from the manufacturers, Cartiva Inc., Wright Medical Group, N.V., and Stryker B.V., indicating that she received a Cartiva implant in March 2018

Following the placement of the Cartiva, Coleman experienced severe pain and other complications that ultimately resulted in a second surgery five years later, on December 21, 2023. She then had the Cartiva implant replaced, and she required a “fusion” surgery due to ongoing severe pain.

The lawsuit blames Coleman’s problems with the Cartiva implant on the Polyvinyl membrane (PVA) used to construct the gel implant. According to the complaint, the implant is prone to loosening, marring and deformation, leading to failure.

“This surgical procedure has not been effective at alleviating pain or restoring range of motion,” Coleman’s lawsuit states. “As a result of the implantation of the Defective Devices, Plaintiff has suffered additional medical expenses for removal of the implant, and thereafter another surgery whereby bone was taken out of Plaintiff and was used to ‘fuse’ her big toe bones together, all of which was needed to correct the toe deformity and bone loss caused by the Defective Device, and causing additional loss of income, and pain and suffering.”

Coleman indicates it took her years to file the lawsuit because the manufacturer deceived federal regulators and hid known problems with the implant from the medical community and patients.

She presents claims of negligent design, misbranded and adulterated device, violations of state and common law claims of product liability and negligence, breach of warranty, failure to warn, violations of the Texas Deceptive Trade Practices Act, and seeks both compensatory and punitive damages.

Cartiva Implant Lawsuits Being Pursued Nationwide

Although the manufacturer suggested Cartiva failure rates were low, Coleman’s and other 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.