The Cartiva synthetic cartilage implant was designed to treat painful arthritis in the big toe while preserving joint movement and avoiding fusion surgery. However, studies and FDA reports have raised concerns about implant failure and other complications, including pain, bone erosion, implant displacement, and the need for additional surgery.
In 2024, the manufacturer recalled all lots of the implant distributed between July 2016 and October 2024. The recall and reported complications have also led to litigation alleging that the manufacturer failed to adequately warn patients and physicians about the device’s risks.
Below, we explain more about the Cartiva toe implant lawsuit, including why the device was recalled and how you can take action if a faulty implant caused injury or death to you or a loved one.
What is the Cartiva toe implant?
The Cartiva synthetic cartilage implant was developed as an alternative to fusion surgery for people with arthritis in the big toe joint. Made from a PVA hydrogel and saline, the implant has physical properties similar to natural cartilage. It was designed to replace damaged areas of cartilage in the first MTP joint while reducing pain and preserving joint motion.
During the procedure, the surgeon prepares the affected area of the joint by removing damaged tissue and any bone spurs. The surgeon then creates a cavity in the metatarsal head and inserts the appropriately sized Cartiva implant into the joint using a press-fit technique.
What is hallux rigidus?
Hallux rigidus means “stiff big toe.” It occurs when the joint at the base of the big toe becomes rigid and painful. As the condition progresses, the joint can become increasingly difficult to move, making activities such as walking painful or uncomfortable.
Treatment for hallux rigidus depends on the severity of the condition. For people who need surgery, options include procedures to remove bone spurs, joint-preserving procedures, or fusion surgery.
The Cartiva synthetic cartilage implant is another surgical option designed to treat arthritis in the first metatarsophalangeal (MTP) joint.
Cartiva toe implant complications
Several studies have raised concerns about complications and potential failure of the Cartiva toe implant. A 2020 study involving 15 patients found that implant subsidence, or sinking of the implant into the surrounding bone, occurred in 79% of patients at the final follow-up. The study also found that 40% of patients experienced erosion of the bone surface next to the implant, while some patients required additional surgery. The researchers ultimately described the failure rate of the polyvinyl alcohol hydrogel implant as high.
A 2024 study reported similar concerns. Among patients in the study, 56% reported pain and inflammation, making it the most commonly reported patient problem. Other reported patient problems included unknown complications in 17% of participants and implant failure in 11%. Device-related problems were also reported, with unspecified device issues affecting 55% of participants, followed by device migration at 20% and implant failure at 18%.
Concerns about the Cartiva implant continued in 2024, when the U.S. Food and Drug Administration (FDA) initiated a recall covering all lots distributed between July 2016 and October 2024. The FDA classified the recall as Class 2, meaning the use of the affected device could cause temporary or medically reversible adverse health consequences.
According to the FDA, the Cartiva implant may cause complications, including pain, nerve damage, movement or sinking of the implant, or the implant breaking apart. Some patients may need another surgery to remove or replace the implant.
Common symptoms of implant failure
Common symptoms of Cartiva implant failure include:
- Nerve damage and numbness
- Reduced range of motion
- Irritation, inflammation, and infection
- Persistent severe pain in other toes
- Cysts and lesions
- Fracture around the implant site
- Shrinking or migration of the implant
- Difficulty walking or standing
- The need for implant removal or surgery
What is the Cartiva implant lawsuit?
On October 31, 2024, the FDA formally announced a recall of all Cartiva toe implants distributed from July 2016 to October 2024. According to FDA data, over a thousand device and patient problems were reported.
Medical device manufacturers have a responsibility to design, test, and provide appropriate safety information for their products before marketing them to the public.
The Cartiva implant lawsuit alleges that Cartiva, Inc. and Stryker Corporation knew or should have known about the device’s risk of failure and other complications but continued to market the implant without adequately warning patients and physicians about those risks.
It is further alleged that the companies misrepresented the safety and durability of the Cartiva implant and failed to adequately disclose information about its potential failure rate.
Joining the Cartiva implant lawsuit
You or a loved one may be eligible to join the Cartiva implant lawsuit if you received the Cartiva toe implant from 2016 to 2024 and had complications, including:
- Nerve damage and numbness
- Reduced range of motion
- Inflammation or irritation
- Severe pain in other toes
- Formation of cysts or lesions
- Infection or fracture in or around the surgical site
- Shrinking or migration of the implant
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Cartiva® is a registered trademark of Stryker Corporation. Their name is used here only for the purpose of identifying the products in question. Woods & Woods, LLC is not affiliated with, sponsored by, or associated with the FDA, Stryker Corporation, or the National Library of Medicine.
