InjuryLWJ
PROFEMUR® MODULAR FEMORAL NECK
Received Feb 13, 2023
Report 3010536692-2023-00019 · MDR key 16362089
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01204Catalog number
PHA01204
Lot number
029820039
Product problems
- Corroded
- Corroded
Patient
Unknown
- Metal Related Pathology
- Metal Related Pathology
Narrative
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem
ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(6). SIDE:L. PRIMARY ASA: P1 - FIT AND HEALTHY. NON-MPO PRODUCTS: PRODUCT ID: 924760000 DURALOC SHELL 100 POLISHED HYDROXYAPATITE COATED 60MM/ LOT. NUMBER: 2732052/ QTY: 1. PRODUCT ID: 124260025 ENDURON PE LINER 10D 32/60 OR 72MM/ LOT. NUMBER: 1878654/ QTY: 1.