TOTAL TALUS REPLACEMENT
Report
- Report Number
- 3014833750-2025-00015
- Event Type
- Injury
- Date Received
- September 3, 2025
- Report Date
- September 17, 2025
- Manufacturer
- RESTOR3D, INC.
- Product Code
- QNN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON REVIEW WITH THE PHYSICIAN, THE IMPLANT WAS NOT THE CAUSE OF THE FAILURE. THE PATIENT EXPERIENCED UNEXPECTED CHANGES WITH THEIR ANATOMY IN THE YEARS FOLLOWING TOTAL TALUS REPLACEMENT. OVER TIME, THE ANKLE JOINT BECAME ARTHRITIC, AND CARTILAGE BROKE DOWN LEADING TO ARTHRITIS AND CYSTS IN THE TIBIA, WHICH WAS FURTHER PROGRESSION OF THE ANKLE JOINT DISEASE FOLLOWING TOTAL TALUS REPLACEMENT.
IT WAS REPORTED THAT THE PATIENT DEVELOPED ARTHRITIS AND CYSTIC FORMATIONS IN THE ANKLE JOINT 3 YEARS FOLLOWING TOTAL TALUS REPLACEMENT SURGERY. THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.
IT WAS REPORTED THAT THE PATIENT DEVELOPED ARTHRITIS AND CYSTIC FORMATIONS IN THE ANKLE JOINT 3 YEARS FOLLOWING TOTAL TALUS REPLACEMENT SURGERY.
IT WAS REPORTED THAT THE PATIENT DEVELOPED ARTHRITIS AND CYSTIC FORMATIONS IN THE ANKLE JOINT 3 YEARS FOLLOWING TOTAL TALUS REPLACEMENT SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2234390 | TOTAL TALUS REPLACEMENT | TOTAL TALUS REPLACEMENT | QNN | RESTOR3D, INC. | IK3-100LT | 20220522-DMP-C-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |