InjuryLWJ
PROFEMUR® MODULAR FEMORAL NECK
Received Nov 1, 2024 · Event occurred Sep 20, 2024
Report 3010536692-2024-00474 · MDR key 20588231
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01252Catalog number
PHA01252
Lot number
0601169350
Product problems
- Break
- Naturally Worn
- Break
- Naturally Worn
Patient
NA · Unknown
- 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, DURING REVISION OF A PATIENT WITH A THA REPLACEMENT IN 2011, A LINER AND NECK FRACTURE WERE IDENTIFIED. THE NECK WAS CONFIRMED ON PREOPERATIVE CT AND THE LINER WAS FOUND TO HAVE BEEN DAMAGED INTRAOPERATIVELY. THE LINER WAS DAMAGED BECAUSE IT PROTRUDED FROM THE CUP. AS FOR THE NECK, IT IS NECESSARY TO INVESTIGATE THE POSSIBILITY OF INTERNAL DAMAGE. JAPAN (B)(4).