PROFEMUR® MODULAR FEMORAL NECK
Received Jun 1, 2023
Report 3010536692-2023-00101 · MDR key 17039111
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01204Catalog number
PHA01204
Lot number
019772187
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Female
- Metal Related Pathology
- Metal Related Pathology
Narrative
Additional Manufacturer Narrative
DUE TO RELIABILITY FINDINGS, THIS DEVICE IS NOT RELATED TO A DEFICIENCY. PLEASE VOID THE FOLLOWING REPORT.
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem
ALLEGEDLY THE PATIENT IS EXPERIENCING MOM COMPLICATIONS (RIGHT). THE PATIENT HAS SCHEDULED TO HAVE THE RIGHT HIP IMPLANT EXPLANTED IN (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED ON 05/11/2023: ALLEGEDLY, DUE TO WE RECEIVED A NEW INFORMATION ABOUT A REVISION SURGERY PERFORMED ON 2023, WE FOUND AN INVOICE OF THE REVISION SURGERY PERFORMED ON 2014, A CONSERVE A-CLASS BFH HEAD MEDIUM NECK 40MM (38AM4000) AND PROFEMUR NECK NEUTRAL LONG COBALT CHROME (PHAC1204) WERE IMPLANTED, THIS MEANS THE HEAD AND NECK IMPLANTED IN THE PRIMARY SURGERY WERE REVISED. THE CUP (PRODUCT ID: 38024854 CONSERVE® PLUS CUP, LOT: 108676882, QTY: 1) IS UNSURE THAT WAS REVISED.