Failure of Cartiva Implant Caused Nerve Damage and Mobility Loss in Big Toe, Lawsuit Alleges

A Texas man blames the Cartiva implant failure on a lack of adequate testing by the manufacturers, who he says hid the device’s failings from the public.

A product liability lawsuit has been filed by a man who says doctors had to fuse his big toe after his Cartiva implant failed due to a defective and unreasonably dangerous design.

The complaint (PDF) was filed by Matthew Mullins earlier this month in Harris County District Court in Texas, pursuing damages against Cartiva, Inc., Wright Medical Group, N.V. and Stryker B.V. as the defendants, indicating that the failure of the toe implant left him with nerve damage and a loss of mobility.

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 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 Cartiva implant lawsuits similar to the one filed by Mullins, each raising allegations that known risks associated with the device were not disclosed to patients and doctors.

Mullins indicates he underwent Cartiva toe implantation. However, by October 2021, he had gone to see a health care professional due to “recurring, ongoing, and immense pain” in his big toe.

He was informed that the cause of his pain was the failure of the Cartiva toe implant. This resulted in a loss of range of motion in his right big toe, loss of mobility, nerve damage, and debilitating pain. Mullins’ lawsuit also states he suffered constant irritation, and discomfort at the location where the failed Cartiva device was implanted.

“As a result of the implantation of the Defective Device, Plaintiff has suffered additional medical expenses for removal of the implant, the implanting of an Artrosurface implant, and thereafter another surgery whereby bone was taken out of Plaintiff’s ankle and was used to ‘fuse’ his big toe bones together, all of which was needed to correct the toe’s deformity and bone loss caused by the Defective Device, and causing additional loss of income, pain, suffering, and impairment,” the lawsuit states.

Mullins indicates the manufacturers failed to adequately design and test the Cartiva implant, failed to warn the public and medical community of its deficiencies, did not properly inform federal regulators of the high rate of failure of Cartiva toe implants, and did not educate doctors or patients on what to look for if the device failed.

Cartiva Implant Lawsuits Being Pursued Nationwide

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, like Mullins, 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.