PROFEMUR® MODULAR FEMORAL NECK
Received Dec 2, 2025
Report 3010536692-2025-00382 · MDR key 23696289
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01242Catalog number
PHA01242
Lot number
076354703
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
68 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem
ALLEGEDLY, PATIENT HAD A MOD Z STEM & NECK, DYNASTY METAL ON METAL ACETABULUM. SURGEON WANTED TO REMOVE THE METAL ON METAL (MOM) INCLUDING THE STEM. HE RETAINED THE DYNASTY SHELL. INSERTED A DUAL MOBILITY LINER AND INSERT. HE REPLACED THE STEM WITH A ZIMMER REVISION STEM AND 28MM CERAMIC HEAD.
Additional Manufacturer Narrative
AFTER RELIABILITY ENGINEERING REVIEW, IT HAS BEEN INDICATED THE COMPLAINT DOES NOT ALLEGE DEFICIENCY IN THE PRODUCT. PLEASE VOID THIS REPORT.