IMPLANT HEAD MOPYC SMALL
Received Sep 26, 2025 · Event occurred Aug 29, 2025
Report 3000931034-2025-00520 · MDR key 23154832
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Tornier S.a.s.Catalog number
PTR-H18
Lot number
9262AN
Product problems
- Break
- Fracture
- Break
- Fracture
Patient
69 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT, THERE IS A BROKEN IMPLANT (PYROCARBON HEAD MOPYC) AND PATIENT REQUIRED REVISION SURGERY. NO FURTHER INFORMATION WAS REPORTED.
Additional Manufacturer Narrative
THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., AND NO SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. THEREFORE, IT IS NOT SUBJECT TO REPORTABILITY UNDER MDR.
Description of Event or Problem
IT WAS REPORTED THAT, THERE IS A BROKEN IMPLANT (PYROCARBON HEAD MOPYC) AND PATIENT REQUIRED REVISION SURGERY. NO FURTHER INFORMATION WAS REPORTED.