PROFEMUR® MODULAR FEMORAL NECK
Received Jun 10, 2024 · Event occurred May 8, 2024
Report 3010536692-2024-00337 · MDR key 19504670
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01232Catalog number
PHA01232
Lot number
V03156729
Product problems
- Naturally Worn
- Naturally Worn
Patient
79 YR · Female
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
WE RECEIVED ADDITIONAL INFORMATION THRU UK NJR THAT THIS PRODUCTS WAS NOT REVISED AND THERE IS NOT ALLEGED DEFICIENCY AGAINST IT.
Description of Event or Problem
ALLEGEDLY, ORIGINAL SURGERY DONE IN 2004, EXACT DATE UNKNOWN. RECENTLY THE PATIENT SUFFERED HIP PAIN AND UNDERWENT A REVISION HIP REPLACEMENT. THE MODULAR NECK, CONSERVE BIG FEMORAL HEAD AND CONSERVE CUP WERE REVISED, AND REPLACED WITH A S&N ACETABULAR SHELL AND LINER (THE SURGEONS STANDARD PRODUCT). A NEW MODULAR NECK WAS INSERTED, ALONG WITH AN MPO CERAMIC HEAD.
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.