Lawsuit Alleges Cartiva Foot Surgery Failed Almost Immediately, Resulting in Need for Removal of Toe Implant and Fusion Procedure

Following higher-than-expected failure rates after foot surgeries involving the synthetic toe implant, a Cartiva recall was issued weeks before the lawsuit was filed.

A Maryland man has filed a product liability lawsuit, alleging that a Cartiva foot implant used during surgery on his big toe was defective and unreasonably dangerous, failing almost immediately after the procedure and resulting in the need for revision surgery to remove the synthetic implant.

The complaint (PDF) was brought by Robert B. Connor in the U.S. District Court for the District of Maryland on December 5, pursuing damages from Cartiva Inc., Wright Medical Group N.V. and Stryker B.V., who were named as defendants.

The Cartiva SCI (Synthetic Cartilage Implant) is a molded cylindrical device constructed of polyvinal alcohol-based hydrogel, which has been promoted for use during foot surgery among individuals experiencing hallux limitus or hallux rigidus, which are types of degenerative arthritis in the first joint of the big toe.

The Cartiva implant was approved by the U.S. Food and Drug Administration (FDA) in 2016, based on clinical trials which only showed a 13% failure rate. However, since the device has been on the market, evidence has pointed to significantly higher Cartiva foot surgery failure rates.

Connor’s lawsuit comes a little more than a month after the manufacturers announced a massive Cartiva recall, acknowledging for the first time that their product was associated with “higher-than-expected” rates of complications among users, many of whom are now pursuing their own lawsuits against the manufacturer, after experiencing painful and debilitating injuries, which typically result in a permanent loss of mobility.

According to his complaint, Connor underwent Cartiva foot surgery in April 2021, after a diagnosis of hallux rigidus in his left foot. However, he indicates neither he nor his doctor were adequately warned about the risk that the Cartiva implant may fail, and the potential consequences.

“Contrary to all representations by Defendants, the SCI has not been effective at alleviating pain or restoring range of motion,” the lawsuit notes. “In fact, Plaintiff has suffered permanent restrictions in the use of his big toe; forced adaptations to account for this restriction in neighboring joints; increased wear and tear on other components of the foot and leg, and; limitations on footwear options and active recreational activities.”

Stryker decided to remove the Cartiva foot surgery implant from the market on October 31, 2024, shortly after a study was published that found patients receiving the device faced a 30 times higher rate of reoperation than patients who underwent alternative procedures. Some earlier findings have suggested that 79% of Cartiva implants fail within two years.

Connor’s lawsuit indicates the manufacturer knew or should have known of these problems years ago, before even placing the implants on the market, presenting claims for strict products liability, negligent design, manufacture and/or distribution, misbranded and adulterated device, common law product liability and negligence, and breach of warranty.

Cartiva Foot Surgery Lawsuits

Following the recent decision to remove the big toe implant from the market, Connor’s complaint is one of a surge of Cartiva lawsuits now being pursued by individuals nationwide.

Product liability lawyers provide free consultations and claim evaluations to help individuals nationwide determine whether they may be eligible for financial compensation for injuries that may have been avoided if the manufacturers had accurately disclosed the Cartiva foot surgery failure rates.

Claims are being investigated 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 recall 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.