Medical device manufacturer Stryker Corporation faces a growing number of lawsuits over failures of its Cartiva Synthetic Cartilage Implant, a toe joint replacement device recalled in October 2024. The Judicial Panel on Multidistrict Litigation will hold a hearing on January 29, 2026, in San Diego to consolidate these cases.
Doyle APC attorneys are reviewing injury claims involving implant subsidence, displacement and migration, severe pain and chronic inflammation, nerve damage and bone erosion, device fragmentation, and cases requiring revision surgery including toe fusion.
What Is the Cartiva Implant?
The Cartiva Synthetic Cartilage Implant is a cylindrical device made of polyvinyl alcohol (PVA) cryogel designed to replace damaged cartilage in the big toe joint. It was developed as an alternative to toe fusion surgery for patients suffering from hallux rigidus, a form of degenerative arthritis affecting the first metatarsophalangeal (MTP) joint.
The device received FDA approval on July 1, 2016, through the Premarket Approval (PMA) pathway, the FDA’s most rigorous regulatory process for Class III medical devices. Approval was based primarily on the MOTION study, a clinical trial comparing the Cartiva implant against arthrodesis (fusion) surgery that reported a revision rate of approximately 13.5 percent within 24 months. Approximately 40,000 Cartiva implants were sold in the United States before the October 2024 recall.
The implant was marketed as a way to preserve motion in the toe joint and avoid the permanent limitations of fusion surgery. However, post-market studies have revealed that most patients who received the device ended up needing the very surgery they tried to avoid.
How the Cartiva Implant Fails
The surgical protocol requires the implant to protrude approximately two to three millimeters above the surrounding bone surface, a positioning called “sitting proud.” This ensures the opposing bone articulates with the smooth hydrogel rather than damaged cartilage.
This positioning creates the fundamental problem behind device failures. During walking, the great toe bears forces equal to 400 to 600 percent of body weight. When the hydrogel is stiffer than the underlying bone, which is common in middle-aged or osteopenic patients, the implant pushes down into the bone rather than compressing. This sinking process, called subsidence, is the most common way the Cartiva implant fails.
Cartiva Implant Complications
Court records and medical literature document a pattern of failures typically occurring within one to three years after implantation.
Implant Subsidence. The most common complication occurs when the Cartiva implant gradually sinks into surrounding bone. The sinking implant creates a crater that makes subsequent fusion surgery far more difficult.
Implant Displacement. Many patients have experienced their implants shifting from the original surgical position. If the implant loosens, it can dislocate entirely, causing sensations of locking or a loose body moving inside the joint.
Hydrogel Fragmentation. The implant material can break apart under stress. Small particles migrate into the joint lining, triggering an inflammatory reaction that causes acute swelling mimicking infection.
Chronic Pain. FDA adverse event reports indicate 56 percent of documented complications involve significant pain and inflammation. For many patients, the pain after receiving a Cartiva implant exceeds their original arthritis symptoms.
Bone Erosion and Nerve Damage. Studies have found bone erosion in 40 percent of patients, caused by the hard hydrogel wearing away the opposing natural bone. Chronic inflammation also increases the risk of nerve injury, potentially causing permanent numbness or painful neuromas.
Revision Surgery Requirements
The vast majority of patients experiencing device failure require additional surgery. Analysis of FDA adverse event reports indicates approximately 73.7 percent of patients reporting problems required surgical removal, and 67.7 percent ultimately underwent toe fusion, the exact procedure the Cartiva implant was supposed to help them avoid.
Post-Cartiva fusion is significantly more complex than primary fusion. Implant removal leaves a substantial hole in the bone requiring structural bone graft, often from the hip or a donor, to bridge the gap and maintain toe length. This increases the risk of non-union, potentially requiring yet another surgery.
Failure Rates Far Exceeding Clinical Trials
Independent post-market studies have revealed failure rates far exceeding the MOTION clinical trial results.
A study published in Foot & Ankle International found evidence of failure in 79 percent of patients at final follow-up. A retrospective study from King’s College Hospital in London found a 29.4 percent reoperation rate in the Cartiva group compared to 0.0 percent in the fusion group. This data supports the claim that Cartiva patients are roughly 30 times more likely to require a second surgery than fusion patients. Even among patients who did not undergo revision, 55 percent reported residual pain and 50 percent reported stiffness.
A Cedars-Sinai Medical Center study reported a 37.5 percent revision rate at an average follow-up of only 20.9 months. The gap between the 13.5 percent failure rate reported to the FDA and the real-world failure rates reaching 79 percent is central to the litigation.
October 2024 Recall
On October 31, 2024, Stryker initiated a voluntary Class II recall of all Cartiva Synthetic Cartilage Implants distributed from July 2016 to October 2024, encompassing all sizes. This comprehensive recall indicates a fundamental design defect rather than an isolated manufacturing issue.
Stryker admitted to “higher-than-expected occurrence rates” of problems including revision, removal, subsidence, displacement, pain, nerve damage, and fragmentation compared to the 2016 PMA application data. Plaintiffs allege the company was aware of serious problems years before taking action, with the volume of adverse events filed from 2021 through 2023 suggesting knowledge of the defect long before the recall.
January 2026 Litigation Update
The Judicial Panel on Multidistrict Litigation has designated the cases as MDL No. 3172, titled IN RE: Cartiva Synthetic Cartilage Implant Products Liability Litigation. The January 29, 2026 hearing in San Diego will determine where consolidated cases will be heard, with plaintiffs requesting transfer to the Southern District of West Virginia.
The push for MDL consolidation began with seven federal cases in October 2025, and the docket continues to grow. Several voluntary dismissals suggest confidential settlements may be occurring. The first bellwether trial, Tammy May v. Cartiva, Inc., is scheduled for August 2026 in West Virginia, with court-ordered mediation set for March 2026.
The Defendants
Stryker Corporation acquired Wright Medical in November 2020 for approximately $5.4 billion. Wright Medical had previously acquired Cartiva Inc. in October 2018 for $435 million. As the surviving entity, Stryker assumed all liabilities of both companies. Stryker has substantial experience resolving medical device litigation and has previously paid over $1 billion to settle claims related to defective hip implants and other devices.
Legal Claims Against Stryker
Because the Cartiva device received PMA approval, plaintiffs must pursue “parallel claims” alleging the manufacturer violated federal regulations in ways that also constitute negligence under state law. The strongest claims center on allegations that Stryker and its predecessors failed to properly report adverse events to the FDA as required by federal regulation, and that had these events been properly reported, the FDA would have required label changes or a recall much sooner.
The lawsuits also allege fraudulent concealment, asserting that the manufacturers knew about unacceptably high failure rates but continued marketing the device while hiding adverse event data. The 2024 recall notice admitting to “higher-than-expected” failure rates serves as evidence the company held data it did not share with the public.
Free Case Evaluation
Have you or a loved one experienced complications with a Cartiva toe implant? If your device has failed, caused persistent pain, or required removal or revision surgery, you may be eligible to file a legal claim for compensation. The October 2024 recall covers all devices implanted between July 2016 and October 2024.
Our experienced medical device attorneys will review your medical records at no cost and explain your legal options. We handle all cases on a contingency basis, which means you pay nothing unless we recover compensation for you. Statutes of limitations restrict the time available to file a claim, so prompt consultation is advisable.
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