About the Cartiva Failure Lawsuit
Osteoarthritis of the big toe can cause debilitating problems like hallux rigidus and hallux limitus. Traditional treatment options for these painful conditions are often limited and often invasive. The Cartiva toe implant was marketed as a groundbreaking alternative to joint fusion surgery, offering hope to patients searching for a better solution.
Unfortunately, Cartiva’s design defects have allegedly been linked to soaring failure rates and a slew of health problems. The device manufacturer, Stryker, is now being sued by patients who received the implant and suffered complications.
If you or a loved one were impacted by Cartiva toe implant failure, you may qualify to file a lawsuit. Learn about eligibility requirements and receive a no-cost consultation with an experienced attorney by completing the form at the top of the page.
Cartiva Toe Implant: Revolutionary Treatment or Risky “Experiment”?
Big toe arthritis is a potentially life-altering problem that impacts more than 2 million Americans. The condition can result from a breakdown of cartilage covering the bones of the metatarsophalangeal joint. It can limit an individual’s mobility, making jumping, running, and walking extremely painful.
For much of modern medical history, arthrodesis—or joint fusion surgery—was the gold-standard treatment for degenerative arthritis of the big toe. Arthrodesis is effective at relieving pain but further limits mobility, making it an undesirable treatment option for active patients.
In the 2000s, medical device producer Stryker introduced the Cartiva implant, a synthetic cartilage device made of a polyvinyl alcohol-based (PVA) hydrogel. The Cartiva device was intended to be implanted into the big toe to “replace” lost or degraded cartilage. Following a set of clinical trials, Stryker requested and received FDA approval for the toe implant in 2016.
Stryker claimed that, along with a mere 13.5% failure rate, the device provided a 128% improvement in mobility and a 91% reduction in pain two years post-operation. A reduced rate of complications was also reported when compared to traditional fusion surgery. Stryker began marketing Cartiva as an “excellent alternative” to joint fusion, emphasizing the device’s ability to reduce pain while preserving anatomical function and range of motion.
Thousands of patients worldwide began opting for the Cartiva toe implant. None may have had reason to believe that Stryker’s claims were too good to be true—but, sadly, lawsuits say this may have been the case. As time went on, some patients began reporting allegedly serious side effects associated with their Cartiva implants, including pain, swelling, migration, fractures, nerve damage, and more.
These adverse outcomes led to further post-market research, which in 2023 revealed an allegedly much greater volume of complications and a failure rate upwards of 64%. In light of the new data, insurance companies began denying coverage for the Cartiva synthetic cartilage implant, deeming it “experimental.” It even prompted a warning from a doctor involved in its development to “NOT GET A CARTIVA IMPLANT until further notice.”
Though many believe it took the company a concerning amount of time to act, Stryker eventually issued a Cartiva recall in 2024. This action was too little, too late, say plaintiffs, who continue to seek justice.
Am I Eligible for the Cartiva Toe Implant Lawsuit?
To qualify for the Cartiva synthetic cartilage implant lawsuit, you must meet several requirements, including:
- You must have received a Cartiva toe implant
- You must have experienced severe or worsening pain in the big toe joint
- You must have suffered loss of mobility or range of motion after surgery
- You must have undergone (or need to undergo) additional surgery to remove the defective implant and/or fuse the joint
- You must have documented complications such as implant loosening, nerve damage, bone loss, or cysts
- You must have been misled about Cartiva’s effectiveness or were not warned of its higher-than-reported failure rate
Additionally, you may qualify if you suffer complications including the following:
- Loss of range of motion in the big toe
- Loss of mobility
- Debilitating toe pain
- Nerve damage
- Irritation or discomfort at the implant site
- Implant loosening or migration (slipping into bone)
- Bone loss or bone overproduction
- Cartiva implant fracture
- Cyst formation
- Infection
- Need for revision surgery (including bone fusion surgery)
- Development of bone spurs requiring additional treatment
What Are The Legal Allegations?
Plaintiffs say companies involved in manufacturing the Cartiva implant (including Cartiva Inc., Wright Medical Group, N.V., and Stryker, B.V.) falsely claimed that device implantation was a simple procedure with a fast recovery time. The Cartiva toe implant was purportedly continually positioned as a less invasive—and more effective—alternative to surgical joint fusion.
Plaintiffs assert that these claims are untrue, citing the tendency for rapid degradation in the device’s PVA layer. Experts say this defect leads to shrinkage, which is what causes the device to fail, results in side effects, and necessitates Cartiva revision surgery.
The defendants are accused of a multitude of serious infractions, including:
- Failure to warn
- Negligence
- Product safety misrepresentation
- Violation of federal regulations
- Failure to conduct adequate safety testing
- Breach of implied and express warranties
- Failure to respond to adverse events
How Do I Join The Lawsuit?
If you believe you meet the eligibility requirements, we suggest speaking with a qualified attorney. Complete the sign-up form at the top of the page to be connected with a Cartiva lawyer in the OCA network at no cost to you.
While considering joining the Cartiva medical device failure lawsuit, you may wonder how much it costs to hire an attorney. Fortunately, many lawyers handling these cases work on a contingency fee basis and do not require upfront payment. Instead, a plaintiff pays a portion of any Cartiva settlement or compensation amount only if their case is successful.
The OCA team is standing by to answer any question you have—and to support you in your fight for justice.
Add Comment