Lawsuit Indicates Cartiva Implant Fails in 2 Out of 3 Patients, But Continued To Be Sold in U.S.

Cartiva implant recall was finally issued in October 2024, following years of concerns about the high failure rate and problems with the device, per Pennsylvania man’s lawsuit.

A Pennsylvania man has filed a product liability lawsuit against manufacturers of the Cartiva SCI big toe implant, indicating that he was left with restricted toe movement and lost his ability to participate in an active lifestyle after the device failed, like it has in many other patients.

The complaint (PDF) was brought by Robert J. Didonato in the U.S. District Court for the Western District of Pennsylvania on February 7, indicating that Cartiva, Inc. knew its toe implant was defectively designed and failing in about two-thirds of patients, but continued to sell the device until at least October 2024, when a Cartiva recall was issued.

The Cartiva SCI (Synthetic Cartilage Implant) is a molded cylindrical device constructed of polyvinal alcohol-based (PVA) 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.

It was approved by the U.S. Food and Drug Administration (FDA) in 2016, based on clinical trials that 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.

As a result of complications experienced by users, Didonato joins a growing number of other patients now pursuing Cartiva implant lawsuits, describing similar problems with painful and debilitating injuries, which typically result in a permanent loss of mobility.

Didonato indicates he received the Cartiva SCI implant in November 2018 in his left foot, and November 2019 for his right foot, after being diagnosed with hallux rigidus. He was told the implants would last 10 to 15 years.

However, in reality Didonato, like many other Cartiva implant recipients, reports a loss of mobility and the need to adapt to the lack of range of motion, which has increased wear and tear on his foot, restricted what kinds of shoes he can wear, as well as limiting his active recreational activities.

The lawsuit warns that PVA is water soluble and the Cartiva implant can shrink and swell, resulting in implant shrinkage, potential detachment from the tissue, and could begin dissolving under pressure from fluid intake and swelling. Didonato indicates that studies have shown the degradation was obvious and avoidable if the Cartiva had been designed differently.

“SCI implants have had degradation of the PVA membrane with findings of loosening, marring and deformity of implant according to an independent study. This degradation directly and proximately causes implant failure, subsequent fusion surgery, pain, loss of mobility and bone loss,” the lawsuit notes. “The PVA degradation is not an anticipated or intended outcome of the manufacturing of the Cartiva SCI but is a mechanical defect that rendered the Cartiva SCI not reasonably safe.”

Didonato presents claims of strict product liability, negligent design, manufacture and/or distribution, misbranded and adulterated device, common law product liability and negligence, breach of warranty, and seeks compensatory and punitive damages.

Cartiva Implant Lawsuits

In the wake of last year’s decision to remove the big toe implant from the market, Didonato’s complaint joins a surge of other Cartiva toe lawsuits now being pursued by individuals nationwide.

Cartiva toe implant lawyers are providing 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.