Lawsuits have been filed by people who needed surgery when their Cartiva toe implant failed or moved out of position, causing severe pain and other complications.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Cartiva Toe Implant induced injury cases in all 50 states. If you or somebody you know was injured or needed surgery for a Cartiva Toe Implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is the Cartiva Toe Implant?
The Cartiva toe implant is a small cylindrical plug that is designed to replace the damaged bone cartilage in patients with big toe arthritis.
What Does It Do?
Cartiva Inc. created this synthetic cartilage toe implant and claimed that it would last a lifetime. It was advertised to provide a durable, low-friction surface to help a person with toe arthritis move with less pain.
What is the Problem?
At first, doctors welcomed the Cartiva toe implant because it provided an easy alternative to toe fusion surgery with a quicker recovery time. However, safety concerns have been growing. A number of medical studies and patient outcomes have shown that the Cartiva toe implant fails in 50% of patients, according to the University Foot & Ankle Institute.
Why Does The Cartiva Implant Fail?
Cartiva failures are usually caused by the implant slipping inside the bone, making it ineffective. This is called subsidence. When it occurs, patients may suffer pain, swelling, nerve damage, loss of mobility, bone loss, and require surgery to remove the implant or fuse their toe.
Study Finds 64% Failure-Rate Within 1 Month
The real risk may be even higher. One study found a 4-week failure rate of 64% among patients who received a Cartiva toe implant. The failure-rate increased dramatically to 79% at 19 months post-surgery.
The study was published in October 2020 in the journal Foot & Ankle Orthopaedics — “Early Failures of Polyvinyl Alcohol Hydrogel Implant for the Treatment of Hallux Rigidus”
Cartiva Warning Label Claims It Has Low Failure-Rate
The study’s shocking 64% failure-rate is almost 5-times higher than the 13.5% rate on the warning label for the Cartiva toe implant, which is what the manufacturer reported to the FDA before it was approved.
The low 13.5% failure-rate was based on a single, limited study called the “Motion Study” that only included 236 patients. New evidence suggests that this study may have significantly underestimated the true risks. Even so, the current manufacturer (Stryker) has failed to investigate these problems or notify the FDA.
Problems Linked to Defective Design
Cartiva toe implant failures may be linked to a defective design. Case reports suggest that it can loosen and move out of position. This may be because the water-based hydrogel shrinks due to a lack of hydration, allowing the smooth implant to slip inside the toe bone.
Patients May Need Multiple Surgeries
When complications occur, patients may need multiple corrective surgeries — including surgery to remove the failed implant, fix complications, fuse the toe joint, or correct other issues that arise. Unfortunately, revision surgeries to remove the Cartiva toe implant and fix these complications are painful, expensive, time-consuming, and may still leave a patient with long-term complications like pain and stiffness.
Other Long-Term Complications After Cartiva Fails
Some patients are in an even worse position due to the amount of bone that was removed to initially implant the Cartiva. Patients may be left with a short toe, which can lead to limping, or changes in the way a person walks that cause new pain in the hips, knees or lower back.
Cartiva Toe Implant Lawsuits
A growing number of lawsuits have been filed by unhappy patients who had to have a Cartiva implant removed or replaced within a few years of their initial surgery, or their doctor is recommending removal.
These lawsuits allege that Cartiva Inc. dramatically underestimated the risks and failed to adequately warn patients or doctors. Dr. Bob Bavarian of the Foot & Ankle Institute calls the Cartiva failures an “epidemic problem” that the manufacturer should investigate.
Post-Operative Side Effects of Cartiva Toe Implant Failures
- Nerve damage
- Severe pain
- Implant moves out of position
- Implant sliding inside the bone (subsidence)
- Increased pain
- Infection
- Bone loss (osteolysis)
- Implant fracture
- Bone over-production
- Loss of flexibility or range of motion
- Need for more surgery
- And more
What is Big Toe Arthritis?
The Cartiva toe implant was approved by the FDA in 2016 for the treatment of big toe arthritis, a painful condition also known as hallux rigidus that affects around 2.2 million Americans.
Symptoms of Big Toe Arthritis
Over time, big toe arthritis destroys the cartilage that covers the ends of the bones in the toe joint, causing the bones to grind together painfully. Bone spurs may also develop around a toe joint with arthritis, making it even more painful to move, or impossible to wear shoes.
Lawsuits for Cartiva Toe Implant Failures
One of the first lawsuits was filed by Cathy A., a woman from Texas who received a Cartiva toe implant in November 2018.
In November 2020, her doctors informed her that the implant had failed, so she underwent another surgery to remove the Cartiva device and implant an Arthrosurface device. In 2021, she underwent a toe fusion surgery due to ongoing problems with severe pain.
The lawsuit was filed against Cartiva Inc., Wright Medical and Stryker on October 14, 2022 in the U.S. District Court for the Western District of Texas — Case Number 1:22-cv-01037-RP.
Do I have a Cartiva Toe Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting Cartiva Toe Implant induced injury cases in all 50 states. If you or somebody you know was injured or needed surgery for a Cartiva Toe Implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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