PROFEMUR® LONG NECK
Received Jun 5, 2025
Report 3010536692-2025-00274 · MDR key 22154255
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA012X4Catalog number
PHA012X4
Lot number
NI
Product problems
- Break
- Break
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ALLEGEDLY, HIP REVISION DUE TO FRACTURED FEMORAL NECK WITH VERY LIMITED INFORMATION AVAILABLE. THE PRIMARY CASE TOOK PLACE 15 YEARS AGO, THERE IS NO USAGE OR DETAILED PATIENT RECORD. THE PRIMARY COMPONENTS CANNOT BE CONFIRMED. PRIMARY COMPONENTS: MODULAR PROFEMUR E STEM, PROCOTYL L SHELL AND A METAL LINER. THE FEMORAL NECK LOOKED LIKE A LONG NECK. DURING THE REVISION THE SURGEON REMOVED THE FRACTURED NECK, HEAD AND STEM. THE SURGEON USED ANOTHER MANUFACTURER'S STEM AND HEAD. A METAL HEAD WAS USED OFF LABEL PER SURGEON?S DECISION NOT TO REMOVE A WELL-FIXED SHELL. THERE IS NO MPO USAGE FROM THE REVISION. NO FURTHER INFORMATION IS AVAILABLE. RELATED MPO PRODUCTS: PRODUCT ID: PHA062XX / PRODUCT: PROCOTYL L SHELL / LOT NO.: NI / QTY: 1. PRODUCT ID: PHA047XX / PRODUCT: RIM-LOCK LINER / LOT NO.: NI / QTY: 1.
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.