Cartiva Implant Lawsuit: MDL 3172 Status and Who Qualifies

The Cartiva Synthetic Cartilage Implant (Cartiva SCI) is a small cylinder of polyvinyl alcohol hydrogel placed into the first metatarsophalangeal joint, the joint at the base of the big toe. Surgeons used it to treat hallux rigidus, the arthritis that makes that joint stiff and painful. It was marketed as a way to relieve pain while keeping motion, instead of fusing the joint solid.

The FDA approved it through premarket approval P150017. FDA records show the Cartiva SCI was approved on July 1, 2016, for painful degenerative or post-traumatic arthritis of the big toe joint. The approval rested largely on a clinical trial (registered as NCT00969969) that compared the implant with fusion.

The plaintiffs say the device did not hold up. In its order creating the MDL, the Judicial Panel on Multidistrict Litigation summarized the claims: patients allege their implant was defective, that they had persistent pain and limited range of motion afterward, and that they needed more surgery to remove the failed implant and fuse the joint. All plaintiffs assert claims for strict liability, negligence, and breach of express and implied warranties.

Complaints quoted by the panel describe implant failure, migration of the implant with swelling and pain, bone loss, and loss of mobility requiring fusion. Law firms handling the cases also allege that the manufacturer knew the failure rate was much higher than the approval data suggested and did not warn surgeons or patients. Plaintiff firms claim post-market studies found failure rates above 60%, compared with roughly 13.5% reported from the approval study. These are allegations; no court has ruled that the implant is defective.

Who makes Cartiva, and who is being sued

Cartiva, Inc., based in Alpharetta, Georgia, developed the implant and is the named defendant in the MDL. Wright Medical Group N.V. acquired Cartiva, and the JPML called Wright its corporate successor, headquartered in Memphis. Stryker later acquired Wright Medical, and Stryker handled the recall notices. Individual complaints name different combinations of these companies.

The recall is the single most important fact for many patients. On October 31, 2024, Cartiva, Inc. began recalling all lots of the Cartiva SCI distributed from July 2016 to October 2024, and the FDA posted the recall on December 4, 2024, as Class 2 recall Z-0598-2025.

The FDA database lists the reason in plain terms: patients may experience a higher than expected rate of revision, removal, implant subsidence, displacement, pain, nerve damage, or fragmentation. The FDA determined the cause was device design. The recall covered the four catalog sizes (6, 8, 10, and 12 mm) and distribution in dozens of states and more than 20 other countries.

The recall did not tell patients to have working implants removed. The notice asked surgeons to keep following patients for new or worsening pain, difficulty walking, skin reactions, stiffness, swelling, or weakness at the big toe joint, to discuss risks and alternatives, and to pull unused implants from inventory. A recall is not a finding of legal fault, but the stated reason and the design cause line up closely with what the lawsuits claim.

If you are not sure which implant you have, your operative report or the implant sticker in your hospital chart will say. The catalog numbers begin with CAR-06, CAR-08, CAR-10, or CAR-12. For how recalls relate to lawsuits in general, see recall vs. class action.

For years, Cartiva cases were scattered across federal courts in Maryland, Kentucky, North Carolina, and elsewhere. Plaintiffs asked the JPML to combine them on October 31, 2025. Cartiva opposed, arguing that different injury theories would dominate and that informal coordination was enough. The panel disagreed.

On February 5, 2026, the JPML created MDL 3172, In re: Cartiva Synthetic Cartilage Implant Products Liability Litigation, and assigned it to Chief Judge Kristine G. Baker of the Eastern District of Arkansas. The panel noted five actions and nine potential tag-along actions pending in seven districts. It chose Arkansas partly because relevant witnesses and evidence are likely near Memphis, where Wright Medical was headquartered. The master docket is 4:26-md-03172-KGB.

The panel listed the common questions: causation, Cartiva's testing of the implant, whether its labeling was adequate, what Cartiva told the FDA during approval, and the circumstances of the recall.

Since then, the court has entered six conditional transfer orders bringing in more cases, scheduled an initial organizational meeting for August 26, 2026, and appointed plaintiff leadership: liaison counsel, two co-lead counsel, and a steering committee. Defense lead counsel is from Duane Morris. The JPML's September 1, 2026 report showed 21 actions pending in MDL 3172. That is small for a multidistrict litigation, and more filings are expected now that there is one court to file in.

No bellwether trial schedule had been published as of September 2026, and there is no global settlement. Cartiva has said it settled some individual cases before they went far, but those amounts are confidential. See what an MDL is for how these cases usually move.

Attorneys reviewing Cartiva claims generally look for three things:

• A Cartiva SCI in your big toe. The recall covers implants distributed from July 2016 through October 2024. Surgery records will confirm the device.
• A failure or serious complication. Common examples are subsidence (the implant sinking into the bone), displacement, fragmentation, loss of motion, and persistent or worsening pain.
• Additional treatment. The strongest cases usually involve revision surgery, removal of the implant, or conversion to a fusion, often with bone graft because of bone loss.

You are less likely to qualify if your implant is doing well, if your problems clearly came from a separate injury, or if your implant was a different product such as a metal or silicone toe joint. Having had the implant does not by itself create a claim; there has to be an injury.

Timing matters. Every state sets its own filing deadline, and in California, for example, a personal injury claim generally must be filed within two years under Code of Civil Procedure section 335.1. Many states start the clock when you knew or should have known the implant failed, which is why a removal surgery date is often important. If you are unsure, a free case review can help you find out whether independent attorneys handling these cases think the deadline is still open.

No one can tell you what a Cartiva case is worth today. There is no settlement grid, no published average, and the few early individual settlements are confidential. As of September 2026, no global Cartiva settlement had been announced and no Cartiva case in the MDL had gone to trial.

In product liability cases like these, damages usually fall into a few categories:

• Medical costs for revision, removal, and fusion surgery, imaging, physical therapy, and future care.
• Lost wages during recovery, which for foot surgery can mean weeks or months off your feet, and any lasting effect on your work.
• Pain and suffering and loss of mobility, including limits on walking, standing, running, or wearing normal shoes.
• Punitive damages in some states, if a jury finds the company acted with conscious disregard for safety. Many complaints ask for these.

Cases with a documented removal and fusion, clear imaging of subsidence, and a preserved implant tend to be the strongest. Cases where the implant is still in place and symptoms are mild are harder. Because this is a mass tort rather than a class action, each person's recovery depends on their own injuries, not an even split. See class action vs. mass tort for the difference.

The main claims in the MDL are standard product liability theories under state law:

• Design defect: the hydrogel implant was unreasonably prone to shrinking, sinking, or breaking down. The FDA recall entry lists device design as the cause.
• Failure to warn: the labeling and patient materials did not accurately convey the risk of failure and revision.
• Negligence: the company did not use reasonable care in testing, monitoring, and reporting problems.
• Breach of warranty: the implant did not perform as promised.

One legal wrinkle is preemption. The Cartiva SCI went through the FDA's premarket approval (PMA) pathway, the strictest route for a medical device. In Riegel v. Medtronic (2008), the U.S. Supreme Court held that federal law preempts many state-law claims against PMA-approved devices that challenge the FDA-approved design or labeling. Plaintiffs in PMA device cases therefore often frame their claims as the manufacturer violating federal requirements, for example by not reporting adverse events to the FDA. Expect the defense to argue preemption; how Judge Baker rules will shape which claims survive.

1. Confirm the device. Request the operative report from your original surgery and look for Cartiva or a CAR catalog number.
2. Protect the implant. If you are scheduled for removal, tell your surgeon and the hospital in writing that you want the explanted device preserved and not destroyed. If it was already removed, ask whether pathology kept it.
3. Get your imaging. X-rays showing subsidence or loosening are key evidence. Ask for copies on disk or through your patient portal.
4. Write down the timeline. Surgery date, when pain returned, what doctors told you, and when you learned the implant failed. The date you learned of the problem can decide whether your claim is on time.
5. Do not sign releases from a manufacturer or insurer without legal advice.
6. Talk to an attorney before the deadline. Independent attorneys who handle these cases can check your records and file in or transfer to MDL 3172. There is no claim form to fill out and no settlement website; each person files a lawsuit.

A free case review takes about two minutes. You can also browse other lawsuits you may be able to join, including cases over hernia mesh and spinal cord stimulators.