InjuryLWJ
PROFEMUR® MODULAR FEMORAL NECK
Received Jun 21, 2024 · Event occurred May 21, 2023
Report 3010536692-2024-00369 · MDR key 19587774
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01204Catalog number
PHA01204
Lot number
V02137467
Product problems
- Break
- Break
Patient
NA · Male
- Pain
- Pain
Narrative
Description of Event or Problem
ALLEGEDLY, THE PATIENT FRACTURED OF THE PROFEMUR MODULAR NECK, BREAKING INTO TWO PIECES. AT THE TIME OF THE FRACTURE THE PATIENT HE FELL AND WAS IN SEVERE PAIN. PRODUCTS NOT REVISED: PRODUCT: LINEAGE® ACETABULAR SHELL 48MM SOLID HEMI FLARE STD GROUP 1 PRODUCT ID: 36450048; LOT#: 09228141; QTY:1. PRODUCT: LINEAGE® CERAMIC LINER 28MM X 46-50MM GROUP 1 PRODUCT ID: 71002846; LOT#: 11358775; QTY:1.
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.