PROFEMUR® MODULAR FEMORAL NECK
Received Jun 15, 2026 · Event occurred May 17, 2025
Report 3010536692-2026-00223 · MDR key 25512067
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01202Catalog number
PHA01202
Lot number
029793169
Product problems
- Loss of Osseointegration
Patient
40 YR · Unknown
- Pain
Narrative
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem
ALLEGEDLY, MPO ITALY RECEIVED OFFICIAL NOTIFICATION SENT BY THE HOSPITAL TO THE MINISTRY OF HEALTH, WITH MPO ITALY COPIED, ON (B)(6) 2026. WE RECEIVED 1 FORM PER DEVICE. THE REPORT STATES THAT THE HCP BECAME AWARE OF THE EVENT ON JULY 17, 2025. FROM THE NECK FORM: THE PATIENT PRESENTED WITH PAIN AND FUNCTIONAL IMPAIRMENT OF THE LEFT LOWER LIMB. PELVIC X-RAYS AND AXIAL VIEW OF THE LEFT HIP SHOWED LOOSENING OF THE FEMORAL NECK COMPONENT. REVISION SURGERY OF THE COMPONENT WAS PERFORMED. ITALY (B)(6) 2026.