Cartiva Synthetic Cartilage Implant Recall

The Cartiva implant was sold as a way to get around a big toe fusion. Instead of locking an arthritic joint in place, a surgeon would set a small plug of synthetic cartilage into the joint, and you’d keep the motion you need to walk, run, and climb stairs.

For patients whose implants failed, the story ended in an operating room anyway, with a surgeon removing the plug and fusing the joint it was supposed to save. Then came the Cartiva synthetic cartilage implant recall in October 2024.

If you’re living with pain, stiffness, or a second surgery, Thomas Law Offices can help you find out whether you have a medical malpractice claim.

What the Cartiva Synthetic Cartilage Implant Recall Means

The FDA approved the Cartiva Synthetic Cartilage Implant in July 2016 to treat arthritis in the big toe joint; a condition doctors call hallux rigidus.

Stryker, which now owns Cartiva, warned surgeons and hospitals on Oct. 31, 2024, that patients could face higher rates of revision, removal, pain, nerve damage, and implants sinking, shifting, or breaking apart at a rate higher than the company’s earlier studies showed.

The recall covers every size and every lot distributed from July 2016 through October 2024. The FDA classified it as a Class 2 recall and listed the cause as device design, according to its recall record.

What does that mean if the implant is still in your foot? The notice asks surgeons to monitor patients for problems, and it stops short of recommending removal.

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Common Symptoms of a Failed Cartiva Toe Implant

Failed Cartiva toe implant symptoms can look a lot like the arthritis that sent you to surgery in the first place. Stryker’s recall notice asks surgeons to watch for:

  • Pain in the big toe joint
  • Difficulty walking
  • Stiffness
  • Swelling
  • Weakness in the big toe
  • Skin reactions

Imaging often explains the pain. In one study of patients who came back with symptoms, MRI showed the bone channel holding the implant had widened past the implant’s own size, and most had fluid collecting around it. Bone loss around an implant is called osteolysis, and it can leave a surgeon less to work with the next time.

Who May Qualify for a Cartiva Lawsuit?

Not everyone who received a Cartiva implant will have a legal claim. However, you may want to speak with an attorney if you experienced complications or other problems after receiving a Cartiva implant, especially if those problems required additional medical treatment. You may qualify for a Cartiva lawsuit if you:

  • Received a Cartiva implant and experienced continued or worsening pain after surgery, particularly if your symptoms persisted despite treatment or initially improved before returning.
  • Experienced problems with the implant or affected joint, including instability, stiffness, swelling, reduced range of motion, or difficulty walking or performing normal activities.
  • Required additional treatment because of complications. This may include additional imaging, injections, physical therapy, hospitalization, or other medical treatment related to problems with the implant.
  • Underwent revision surgery or implant removal. If your Cartiva implant had to be removed, replaced, or addressed through another surgical procedure, an attorney may be able to evaluate whether the complications support a claim.
  • Suffered financial losses because of your injury. Medical expenses, missed work, reduced income, and other costs associated with complications may be relevant when evaluating a potential case.
  • Experienced lasting impairment or limitations. A Cartiva-related injury that results in permanent pain, reduced joint function, loss of motion, or other lasting limitations may warrant a legal evaluation.

The circumstances surrounding every Cartiva case are different. Factors such as your medical records, the condition of the joint before implantation, the symptoms you experienced afterward, the treatment you required, and the timing of those events can all be important when determining whether you may have a claim.

If you received a Cartiva implant and believe something went wrong, an attorney can review your medical history and explain whether your circumstances may support a claim.

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Why Cartiva Implants Are Failing at High Rates

The Cartiva SCI is a small cylinder of hydrogel pressed into the end of a foot bone. Studies point out three ways it goes wrong.

  1. It shrinks. In a 2020 study of patients who came back with symptoms, almost everyone had received a 10 mm implant, but on MRI the implants measured 9.7 mm on average, inside bone channels that had widened to 11.2 mm. That’s a problem. Fourteen of 18 showed fluid collecting around the implant.
  2. It sinks. A 2021 study found the implant had sunk into the bone in nine of 10 patients by final follow-up. Half showed bone loss around it. Doctors call that osteolysis, and osteolysis after Cartiva surgery can leave a surgeon with less bone to work with the next time.
  3. It fails more often than fusion. A 2024 review of 18 studies found a 14.8 percent failure rate for the implant versus 9.0 percent for fusion, with Cartiva SCI complications at 27.9 percent versus 24.1 percent. In a 2019 U.S. series, 20 percent of patients needed another operation within about 18 months, and 38 percent were unsatisfied or very unsatisfied.

Not every failure traces back to the device. If a surgeon chose the wrong size or placed the implant poorly, that could be medical negligence, a separate claim.

Revision Surgery: The Fusion You Were Trying to Avoid

When a Cartiva implant fails, many surgeons remove it and fuse the big toe joint. Some replace the implant instead.

Fusion usually eases the pain. However, it also ends motion in the joint for good, which is exactly what you had the Cartiva surgery to prevent. A fusion done after a failed implant also starts at a disadvantage. A 2025 study found these revision fusions failed to heal more often and left patients with worse function than first-time fusions.

Meanwhile, you’re facing another surgery, another stretch in a boot or on crutches, and more time away from work, all to undo a procedure that was supposed to be the “easier” path to solving this problem.

Federal Cartiva lawsuits are now grouped in a single multidistrict litigation, or MDL, before Chief Judge Kristine G. Baker in federal court in Little Rock, Arkansas, where each patient keeps an individual case. Product liability claims over Cartiva center on two theories: a design defect (the FDA itself listed device design as the recall’s cause) and failure to warn surgeons and patients how often the implant failed.

Those claims face a hurdle that many injury cases don’t. The FDA approved Cartiva through premarket approval, its most demanding review, and federal law blocks claims that simply second-guess an approved design or label. To survive, a claim generally must tie the defect or missing warning to a violation of the federal requirements that came with that approval.

Building this kind of claim takes lawyers who know where those lines fall.

Our firm also handles other failed-implant cases, including implanted port catheter injuries. Thomas Law Offices provides nationwide legal representation for patients hurt by defective medical devices.

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Steps to Take If You Suspect Your Implant Is Defective

If you believe your Cartiva implant may be failing or causing complications, document what you’re experiencing and preserve information about the device. The steps you take now may also help your medical providers determine what is causing your symptoms and help preserve information that could be relevant to a potential legal claim.

  • 1. Talk to your surgeon about imaging and other medical evaluations.
    If your pain, swelling, stiffness, instability, or other symptoms return or worsen, contact your surgeon or another qualified medical professional. Depending on your symptoms and medical history, your doctor may recommend X-rays, an MRI, or other testing to determine whether the implant has shifted, deteriorated, or otherwise contributed to your symptoms. Follow your doctor’s recommendations for evaluation and treatment rather than assuming the implant is the cause of your problems.
  • 2. Request your medical and implant records.
    Ask your surgeon, hospital, or medical provider for copies of your operative report, implant records, surgical records, and relevant imaging. These records may contain important information about the procedure, including the specific implant used, the date it was implanted, and other details about your treatment. Keep copies of your records in a safe place rather than relying on your medical provider to maintain them indefinitely.
  • 3. Ask that the implant be preserved if it is removed.
    If revision surgery becomes necessary, tell your surgeon and the hospital in writing that you want the removed implant preserved rather than discarded. The removed device and related medical evidence may potentially be relevant to determining what happened and evaluating a legal claim. Because medical facilities have their own procedures for handling explanted devices, make the request before surgery whenever possible and ask how the device will be handled after removal.
  • 4. Keep a detailed record of your symptoms and financial losses.
    Document when your symptoms began, how they have changed, and how they affect your daily life. You may also want to keep records of medical appointments, procedures, prescriptions, medical expenses, transportation costs, missed work, and other out-of-pocket expenses. If your condition has affected your ability to work, document missed time, reduced hours, or other employment-related losses. A contemporaneous record can help provide a clearer picture of the impact your complications have had on your life.
  • 5. Be cautious before signing documents related to your potential claim.
    If a manufacturer, insurance company, or other party asks you to sign a release, authorization, settlement document, or broad medical-record authorization, consider speaking with an attorney first. Once you sign certain documents, you may give up legal rights or authorize access to information beyond what is necessary to evaluate your situation. An attorney can explain what a document means and whether signing it could affect a potential claim.

Potential Compensation in a Cartiva Lawsuit

If you have experienced complications related to a Cartiva implant, you may be entitled to seek compensation for losses associated with your injury. The damages available in a particular case depend on the facts, the applicable law, and the evidence supporting the claim.

Potential compensation may include:

  • Medical expenses: This may include the cost of treating complications associated with the implant, including revision surgery, hospitalization, diagnostic testing, rehabilitation, medications, and other necessary medical care.
  • Future medical care: If your injury requires continuing treatment or additional surgery, a claim may seek compensation for reasonably anticipated future medical expenses.
  • Lost wages: If your condition caused you to miss work, your claim may include income you lost while recovering or receiving treatment.
  • Reduced earning capacity: In some circumstances, a serious injury may affect your ability to perform your job or continue working at your previous level. Depending on the evidence, damages may account for the resulting reduction in earning capacity.
  • Pain and suffering: Compensation may also be available for physical pain, discomfort, limitations, and the emotional impact associated with an injury and its treatment.
  • Permanent impairment or disability: If complications result in lasting limitations, such as reduced range of motion or permanent impairment of the affected joint, those effects may be considered when evaluating damages.

Every case is different. The amount and types of compensation available will depend on factors such as the nature and severity of the injury, the treatment required, the effect on employment and daily activities, and the applicable law.

Talk to a Cartiva Implant Lawyer at Thomas Law Offices

A defective or failed medical implant can turn a procedure that was supposed to relieve pain into a new source of uncertainty, additional treatment, and unexpected expenses. If you experienced complications involving a Cartiva implant, you may have questions about what happened, what evidence you should preserve, and whether you have a legal claim.

Thomas Law Offices represents individuals who have suffered injuries associated with defective medical devices and other dangerous products. The firm is based in Louisville and has offices in Chicago, Cincinnati, and Columbia, Missouri.

If you believe a Cartiva implant caused you harm, an attorney can review your medical history, treatment records, and other information to determine whether your circumstances may support a claim. Because legal deadlines can apply to product liability and medical-device cases, it’s important not to wait too long to seek legal advice.

Contact Thomas Law Offices for a free case evaluation and to discuss your situation with a member of the firm’s legal team.

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