If you received a Cartiva Synthetic Cartilage Implant in your big toe and later experienced worsening pain, implant failure, or required revision surgery, you may be eligible to pursue a Cartiva toe implant lawsuit.
In October 2024, the Cartiva implant was recalled after evidence showed significantly higher failure rates than originally disclosed. Our firm represents patients nationwide harmed by defective medical devices, including failed orthopedic implants.
What Is the Cartiva Toe Implant?
The Cartiva Synthetic Cartilage Implant (SCI) is a cylindrical implant made from a polyvinyl alcohol (PVA) hydrogel. It was used to treat arthritis of the big toe joint (hallux rigidus) by preserving motion and avoiding fusion surgery.
The implant was marketed to patients and physicians as:
- A motion-preserving alternative to fusion
- A minimally invasive solution
- A long-term fix for big toe arthritis
However, real-world outcomes have shown that many patients experienced implant failure instead of relief.
FDA Recall and Safety Warning (October 2024)[1]
On October 31, 2024, Cartiva and its parent company, orthopedic giant Stryker[2], issued an urgent medical device recall covering all Cartiva toe implants distributed from July 2016 through October 2024. The FDA classified the recall as Class II, citing evidence that patients implanted with Cartiva may experience unexpectedly high rates of serious complications, including:
- Implant failure requiring revision or removal
- Implant subsidence (sinking or shrinking into bone)
- Implant displacement or migration
- Chronic or worsening pain
- Nerve damage
- Fragmentation or degradation of the implant
Doctors were instructed to stop using the device and to closely monitor implanted patients for worsening symptoms.
[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210909
[2] https://www.stryker.com/content/dam/stryker/foot-and-ankle/resources/CartivaFSN30Oct2024_US.pdf
High Failure Rates in Clinical Practice
Independent studies and post-market data show that the Cartiva implant has failed at far higher rates than early trials suggested. Published analyses have reported:
- Failure or removal rates exceeding 60% in some patient groups
- Radiographic evidence of implant shrinkage, loosening, and bone erosion
- Progressive arthritis despite implantation
- Frequent need for revision surgery, often conversion to permanent toe fusion
For many patients, the Cartiva implant ultimately resulted in the exact surgery it was meant to avoid.
Common Cartiva Implant Failure Symptoms
Patients harmed by Cartiva toe implants commonly report:
- Persistent or worsening big toe pain after surgery
- Loss of range of motion
- Swelling, stiffness, or instability
- Difficulty walking or bearing weight
- Implant loosening or migration
- Need for implant removal or fusion surgery
- Permanent mobility limitations
If these symptoms sound familiar, your experience may be consistent with documented Cartiva implant failure patterns.
Cartiva Toe Implant Lawsuits: What Is Being Alleged?
Lawsuits filed against Cartiva, Wright Medical, and Stryker allege that the manufacturers:
- Underreported true failure rates to the FDA and public
- Relied on limited studies that did not reflect real-world outcomes
- Failed to warn patients and surgeons of known risks
- Continued marketing the implant despite mounting adverse data
- Delayed recall long after safety concerns were apparent
Claims commonly include defective design, failure to warn, and violations of federal medical-device regulations.
Do I Have a Cartiva Toe Implant Claim?
You may have a viable Cartiva lawsuit if:
- You received a Cartiva Synthetic Cartilage Implant
- You experienced persistent pain, implant failure, or worsening symptoms
- You required revision surgery or fusion
- Your implant failed within months or years of surgery
Each case depends on medical records, timing, and injury severity—but many patients harmed by Cartiva meet these criteria.
Speak With a Cartiva Implant Lawyer
Our firm is actively investigating Cartiva toe implant claims nationwide. We help injured patients pursue compensation for:
- Medical expenses and revision surgeries
- Pain and suffering
- Loss of mobility and quality of life
- Future medical care
Consultations are confidential, and there is no obligation to proceed. Time limits apply, so prompt evaluation matters.
REQUEST A FREE CONSULTATION
Contact the experienced litigation attorneys at Harrison Davis to schedule a free consultation and get the answers you need.
