Cartiva Toe Implant: Risks, Recovery Time & Legal Concerns
The Cartiva toe implant is used to treat big toe arthritis. About the size of a bullet, it serves as an alternative to joint fusion surgery. In 2024, Stryker issued a recall of all Cartiva implants after new data showed high failure and complication rates. About 22,000 people were implanted with the device before the recall. Some of those people have now filed lawsuits.
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What Is a Cartiva Toe Implant?
The Cartiva toe implant is a treatment option for big-toe arthritis that was initially introduced to the market in 2016. When cartilage deteriorates in the big toe area, bones begin rubbing together. This can be incredibly painful for patients.
The implant is made of an organic hydrogel polymer and works by replacing areas of damaged cartilage near the big toe. The device was meant to reduce pain from big toe arthritis while helping the patient maintain their range of motion.
The introduction of the Cartiva toe implant was significant, as it was meant to serve as an alternative to the more common treatment option of joint fusion surgery.
The procedure to place the implant was faster and included a quicker recovery time than joint fusion, while also ideally leaving patients with full range of motion in their big toe, which isn’t possible if the joint is fused.
More than 20,000 people have been implanted with the device.
Cartiva Toe Implant Benefits and Limitations
The primary benefit of the Cartiva toe implant is its ability to replace joint fusion surgery as a treatment option for big toe arthritis. This offers patients another option to alleviate their pain and may also help them retain mobility.
“The viscoelastic hydrogel implant’s material properties are conducive to replacing focal areas of damaged cartilage providing pain reduction and maintaining range of motion,” the device’s summary of data on its safety and effectiveness stated.
This was a major departure from the typical fusion treatment, which lessens or eliminates pain but also removes the patients’ ability to move their big toe.
The implant benefited from promising early data before it hit the market. Over 98% of people who received the implant as part of a clinical study either maintained or improved their function.
Additionally, about 87% of people implanted had a “clinically significant” increase in function.
Complications and Injuries Linked to the Cartiva Implant
Limitations of the Cartiva toe implant became more apparent in the years following its introduction, eventually leading to its recall. One issue that emerged is known as subsidence, when the implant may slip into the bone.
This can cause pain and loss of mobility. Some people have reported experiencing persistent or worsening pain after their procedure.
Revision Surgery
Revision surgery is another major potential complication of the Cartiva toe implant is the need for. If the implant is unsuccessful and pain continues or worsens, removal of the implant may be necessary.
In addition, patients who have their implant removed may also go on to need joint fusion surgery to alleviate the pain and discomfort caused by big toe arthritis.
Cartiva Toe Implant Recall and FDA Actions
In October 2024, Stryker announced a recall for all Cartiva toe implants. The recall was based on data gathered after the device was launched, showing that patients could experience higher-than-expected rates of serious complications.
- Nerve damage
- Pain
- Revision or removal of the implant
- Subsidence
- The implant being displaced or fragmenting
“Cartiva SCI devices have been observed in some cases to be revised/removed at higher rates than previously observed,” Stryker said at the time in its recall notice.
The Food & Drug Administration listed Cartiva as a Class II recall. According to the agency’s website, a Class II recall constitutes a situation where a device “may cause temporary or medically reversible adverse health consequences.”
What the Recall Means for Patients
As part of the recall, doctors were told to closely monitor patients who had already received the device. This included watching for signs of conditions like pain, difficulty walking and joint weakness.
The recall noted that “the long-term effects of cartilage replacement are not known.
Why Are People Filing Cartiva Toe Implant Lawsuits?
People have begun filing Cartiva toe implant lawsuits after their implants failed, required additional surgeries or worsened their condition.
Many lawsuits center on claims that the device ended up slipping into the patient’s bone. People who have filed cases claim that this has caused or even worsened the type of pain that the implant was designed to alleviate.
Cartiva toe implant lawsuits also claim that device failure led to the need for additional surgical procedures, both to remove the failed device and to undergo the joint fusion surgery that the implant was supposed to prevent.
One example of a Cartiva lawsuit involved a man who received the implant to treat big-toe arthritis. He chose to undergo the procedure in part because he was told it would lead to a faster recovery time.
Following device implantation, the man developed pain and stiffness in his right foot, with limited range of motion. As the pain continued, the implant eventually needed to be removed.
Current Status of Cartiva Toe Implant Lawsuits
In February 2026, the Cartiva toe implant lawsuits were consolidated into multidistrict litigation (MDL). This was a major step for these lawsuits, placing all federal cases before one judge for coordinated proceedings.
MDLs allow for a more streamlined and efficient legal process, helping to avoid duplicative efforts or contradictory results.
They also often culminate in bellwether trials, where several cases considered representative of the larger litigation are selected to go before a jury.
Your Legal Options
You may be eligible to file a lawsuit if you experienced complications after receiving a Cartiva toe implant. Some of the issues commonly listed in lawsuits include continuing or worsening pain after receiving the implant, along with the need for additional procedures.
Some patients have gone on to need their implant removed and undergo joint fusion surgery as an alternative.
If you had surgery or are planning to, check with your doctor about preserving your implant. It could be important evidence in your lawsuit.
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