PROFEMUR® MODULAR FEMORAL NECK
Received Jun 15, 2026 · Event occurred May 1, 2026
Report 3010536692-2026-00220 · MDR key 25512064
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01202Catalog number
PHA01202
Lot number
1977457
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem
ALLEGEDLY, ON (B)(6) 2023: THA WAS PERFORMED AND THE DEVICES WERE IMPLANTED. AROUND ON (B)(6) 2026, THE PATIENT PRESENTED WITH PAIN AT A DIFFERENT FACILITY FROM THE ORIGINAL SURGERY HAD BEEN PERFORMED, HOWEVER THE CRP LEVEL WAS LOW. ON (B)(6) 2026, AN INCREASE IN CRP WAS OBSERVED AND IT WAS JUDGED TO BE AN INFECTION. A REVISION SURGERY WAS PLANNED. ON (B)(6) 2026, A REVISION SURGERY WAS PERFORMED, AND THE CUP, HEAD AND THE NECK WERE REPLACED. SINCE THERE WAS NO LOOSENING OF THE STEM, THE STEM WAS NOT REPLACED. OC-00000783.