Cartiva SCI toe implant lawsuit MDL 3172: the synthetic cartilage hydrogel failure rate, the October 2024 Stryker recall, and the centralized litigation that emerged in February 2026

The Cartiva Synthetic Cartilage Implant (SCI) is a small polyvinyl alcohol hydrogel device, roughly the size of a pencil eraser, designed to treat hallux rigidus (a degenerative arthritis of the big toe joint that causes pain, stiffness, and reduced mobility). FDA approved the device in 2016, marketing emphasized that it preserved joint motion (unlike fusion surgery, which alleviates pain but eliminates motion), and the procedure was adopted enthusiastically by foot and ankle surgeons through the late 2010s. The implant was acquired by Stryker in 2018 for $435 million.

The trouble appeared in post-market data. Initial trials had reported failure rates around 13%. Surgeon-level data accumulating through 2020-2024 suggested the actual rates were substantially higher, with some published series reporting failure rates approaching two-thirds of all procedures. The failure modes were specific: subsidence (the implant sinking into the underlying bone), fragmentation (the hydrogel material breaking apart), migration (the implant displacing from the prepared site), and bone loss around the implant cavity. When the device failed, the typical revision was fusion surgery, which was the procedure the Cartiva implant was originally promoted as avoiding.

In October 2024, Stryker issued a Class 2 Device Recall for all Cartiva SCI sizes, acknowledging the higher-than-expected failure rates. The recall was not a market withdrawal in the sense that all existing implants had to be removed; it was a notification to surgeons that the device should not be implanted in new patients pending further evaluation. By that point, an estimated 13,000 to 15,000 patients had received Cartiva implants in the United States since 2016.

The MDL

The Judicial Panel on Multidistrict Litigation centralized federal Cartiva lawsuits into MDL No. 3172 (In re: Cartiva Synthetic Cartilage Implant Products Liability Litigation) on February 5, 2026. The MDL sits in the U.S. District Court for the Eastern District of Arkansas before Judge Kristine G. Baker. The Arkansas venue was chosen in part because Cartiva, Inc. (the original developer) was headquartered in Alpharetta, Georgia but had substantial business operations through Arkansas suppliers, and the JPML weighed the convenience-of-parties analysis in favor of Eastern District of Arkansas.

The MDL consolidates discovery, expert development, and pretrial proceedings. Each plaintiff still maintains an individual case; the MDL provides procedural efficiency without converting the cases to a class action. Common issues that will be developed centrally include the science around hydrogel implant failure modes, Stryker's pre-recall awareness of the failure rates, the adequacy of the 2016 FDA approval data, and the post-market surveillance practices.

Two earlier bellwether trials had been scheduled in state court (West Virginia state cases involving plaintiffs Hughes and May), but both were delayed to August 2026 by joint motion. The MDL centralization may produce different bellwether selections; the MDL court will set the bellwether process once the case management orders are entered.

The science

Hallux rigidus is osteoarthritis at the first metatarsophalangeal joint (the base of the big toe). The cartilage in the joint degrades over time, the joint stiffens, and motion at the big toe becomes painful or impossible. For early-stage hallux rigidus, conservative treatment (orthotics, anti-inflammatories, joint injections) is often effective. For advanced-stage cases where conservative treatment fails, surgical options are fusion (arthrodesis), arthroplasty (joint replacement with various implant materials), and the Cartiva SCI hemiarthroplasty (partial joint replacement with the synthetic implant on the metatarsal head side).

Fusion is the gold standard for end-stage hallux rigidus. It eliminates the pain by eliminating motion at the joint. Patients accept the loss of big toe motion in exchange for pain relief and durability; fusion procedures have very low revision rates and reliable long-term outcomes.

The Cartiva SCI was positioned as the motion-preserving alternative. The implant goes in the metatarsal head, the joint retains motion, and patients in theory get pain relief without the activity restrictions that follow fusion. The 2016 FDA approval was based on a multicenter trial (the MOTION trial) that reported satisfactory outcomes at two years.

The post-market data is where the picture changes. Larger, longer-term series began reporting higher failure rates and earlier failures than the MOTION trial had suggested. A 2024 study by Fletcher et al. in Bone & Joint Open reported mid-term failure rates substantially above the FDA-trial reported rates. Multiple foot and ankle surgery thought leaders raised concerns about the implant's durability in clinical practice settings that differed from the controlled MOTION trial conditions.

The failure modes share a common biomechanical issue: the hydrogel material does not integrate with surrounding bone, and the mechanical loading at the first metatarsophalangeal joint (which sees substantial force with every step) progressively damages either the implant, the underlying bone, or both. Subsidence is the most common failure mode; the implant gradually sinks into the metatarsal head bone as the bone underneath remodels under load.

The liability theory

The Cartiva litigation framework combines two related theories.

The defective design theory argues that the implant's failure rate is intrinsic to its hydrogel-on-bone biomechanical design, that the 2016 FDA approval did not adequately demonstrate long-term durability, and that Cartiva (and later Stryker) should have understood the failure risk based on the material science. The defense response is that FDA approved the device based on the available evidence at the time, and post-market failure rates reflect both the inherent uncertainty of new device approvals and patient-specific factors (BMI, activity level, bone quality) that affect any joint replacement.

The failure-to-warn theory argues that as post-market data accumulated through 2020-2024, Stryker had a duty to update warnings to surgeons and patients about the actual failure rates rather than continuing to market the implant based on the original FDA-trial data. The October 2024 recall is, in this framing, what should have happened in 2022 or earlier. The defense response emphasizes that adverse event reporting was timely and that the 13% original failure rate was within the range of similar joint implant devices.

For individual plaintiffs, the case theory depends on when the implant was placed and what was known at the time:

Patients implanted in 2016-2019 (early adoption period) face a tougher causation challenge because the post-market data was still developing and Stryker can credibly argue it acted on the best available information.

Patients implanted in 2020-2023 (substantial period after adverse event reports were emerging) have a stronger failure-to-warn theory.

Patients implanted in 2024 after October (post-recall) generally have a stronger case still, because the device was on the recall list when implanted.

What documentation matters

The substantial documentation requirements for a Cartiva case:

Surgical records. The operative report identifies the specific implant used (Cartiva SCI), the size, the lot number, and the surgeon who placed it. Without this documentation, identifying which device was implanted is difficult.

Imaging documentation. Pre-implantation x-rays establishing the hallux rigidus diagnosis. Post-implantation x-rays at follow-up intervals showing the implant's position. Imaging at the point of suspected failure showing the failure mode (subsidence, fragmentation, migration).

Revision surgery documentation if applicable. Many cases involve a revision to fusion surgery after the implant fails. The revision operative report documents the failure mode and the extent of bone loss.

Symptom documentation. Pain levels before and after implantation, activity limitations, work impact, additional medical treatment.

Functional impact. Loss of mobility, inability to return to previous activity level, occupational impact (particularly for patients whose work involves standing or walking).

Statute of limitations

Most states give two to four years from the date the plaintiff knew or reasonably should have known the injury was related to the Cartiva implant. The discovery rule applies in most jurisdictions, and the October 2024 recall is widely treated as a constructive notice point for patients whose implants had failed by that date.

For patients whose implants failed before October 2024, the limitations clock may have started running at the point of failure or at the point a treating physician connected the failure to the device design rather than to patient-specific factors. The analysis is fact-specific.

For patients whose implants were placed before 2024 and have not yet failed but are showing signs of subsidence or migration on follow-up imaging, the limitations period has not started; the injury is the failure, not the implantation.

How Cartiva fits into the broader mass tort landscape

The framework shares features with several Halstonberg-covered device litigations:

Bard PowerPort catheter involves a similar narrative of post-market data revealing higher-than-expected failure rates in an FDA-approved implantable device.

Exactech recall involves a joint implant device (knee and hip components) with substantial failure rate disclosures.

Stryker hip implants involves the same parent company (Stryker, post-2018 acquisition of Cartiva). The Stryker hip implant litigation framework is established, and the discovery materials may overlap with Cartiva discovery on questions about Stryker's post-market surveillance practices.

Bard hernia mesh and Atrium C-Qur hernia mesh involve similar implantable medical device failure-rate narratives, though the device biomechanics are obviously different.

The Cartiva framework is at an earlier procedural stage than any of those. The MDL is three months old as of the time of writing; discovery is just beginning; bellwether selection has not happened. The case values will not be clear until the bellwether trials produce verdict data.

Practical guidance

If you received a Cartiva SCI implant and it has failed, the litigation is currently active. The MDL is accepting new filings, and most firms handling these cases work on contingency.

If you received a Cartiva SCI implant and it has not failed but you are concerned, the relevant action is medical monitoring rather than legal action. Periodic follow-up x-rays at six to twelve month intervals can detect subsidence or migration early; revision options are better when caught before substantial bone loss occurs. There is no claim available based on implantation alone; the injury is the failure.

If you received a Cartiva SCI implant and have already had revision surgery to fusion, you are in the strongest documentary position. The revision operative report documents both the failure mode and the consequence (loss of joint motion that the Cartiva implant was specifically marketed as preserving).

Consult counsel handling MDL 3172 cases for individual case evaluation. Most firms offer free consultations, and the case work-up will tell you within the first conversation whether your specific surgical and post-surgical history fits the active case profile.

The 2024 recall was the late acknowledgment that the device had a problem. The 2026 MDL is the legal framework for resolution. The case will likely take 18-36 months to reach substantial bellwether verdicts; settlement discussions tend to follow.