PROFEMUR® MODULAR FEMORAL NECK
Received Nov 7, 2023 · Event occurred Oct 12, 2023
Report 3010536692-2023-00202 · MDR key 18085749
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01252Catalog number
PHA01252
Lot number
1969147
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
86 YR · Female
- Pain
- Ambulation or Postural Difficulties
- Pain
- Ambulation or Postural Difficulties
Narrative
Additional Manufacturer Narrative
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem
ALLEGEDLY, SHE COMPLAINED OF PAIN ONE WEEK PRIOR TO THE VISIT AND WAS UNABLE TO GET UP ON THE DAY OF THE VISIT. AS FOR HER ACTIVITY, SHE SAID THAT SINCE IT HAD BEEN ONLY 3 MONTHS SINCE THE SURGERY, SHE COULD ONLY WALK AROUND THE HOUSE, AND HIS MAIN EXERCISE WAS TO GET UP. (SHE IS NOT BEDRIDDEN). BHA PERFORMED ON (B)(6) FOUND TO BE DISLOCATION ON (B)(6) AND THA WAS REPLACED AGAIN ON (B)(6). JAPAN (B)(4).