Cartiva SCI
OpenFILINGCausation
Plaintiffs allege the Cartiva SCI device is defectively designed. The PVA hydrogel implant degrades in vivo, losing structural integrity and fragmenting within the first metatarsophalangeal joint. Implant failure causes chronic inflammation, bone cyst formation, osteolysis (bone loss), and severe pain requiring revision surgery — typically the fusion procedure the implant was meant to avoid. Post-market surveillance and clinical registries show failure rates significantly higher than the 10-year data presented in the original 510(k) clearance. Plaintiffs argue Stryker and Cartiva knew or should have known about elevated failure rates from European market data before aggressively marketing in the US.
Defendants
| Entity | Role | Note |
|---|---|---|
| Stryker Corporation | Current Manufacturer | Acquired Cartiva Inc. in 2020 for $430M — assumed all product liabilities |
| Cartiva Inc. | Original Manufacturer | Developed and initially marketed the SCI device before Stryker acquisition |
Litigation Timeline
Intelligence Signals
Official JPML monthly report. Historical total 22. Judge Kristine G. Baker, ARE.
Key Facts
- Status
- active
Geographic Exposure
Eligibility Criteria
- ✓Had a Cartiva SCI device implanted in the big toe joint
- ✓Experienced implant failure, migration, or disintegration
- ✓Suffered chronic pain, bone erosion, or joint deterioration after implantation
- ✓Required revision surgery (typically fusion) to address failed implant