PROFEMUR® MODULAR FEMORAL NECK
Received Jun 21, 2024
Report 3010536692-2024-00366 · MDR key 19586558
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01214Catalog number
PHA01214
Lot number
UNKNOWN
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
57 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ALLEGEDLY, PATIENT WAS REVISED DUE TO HEAD/SOCKET MISMATCH - SOCKET. SRNJR NUMBER: (B)(6). SIDE: L GENDER: M NON MPO DEVICES: 121712064 PINN SECTOR HA ACET CUP 64MM, 121936164 PINNACLE MARATHON PE LINER +4 10 DEGREE 64X36MM AND 121730500 PINNACLE 6.5 CANCELLOUS SCREW 30MM (DEPUY).
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Additional Manufacturer Narrative
DUE TO ADDITIONAL INFORMATION RECEIVED, IT HAS BEEN INDICATED THE COMPLAINT DOES NOT ALLEGE DEFICIENCY IN THE PRODUCT. PLEASE VOID THIS REPORT.