inforMED
InjuryLWJ

PROFEMUR® MODULAR FEMORAL NECK

Received Sep 19, 2023 · Event occurred Aug 29, 2023

Report 3010536692-2023-00169 · MDR key 17774564

Device

Generic name

Hip Component

Model number

PHA01252

Catalog number

PHA01252

Lot number

1969682

Product problems

  • Detachment of Device or Device Component
  • Device Dislodged or Dislocated
  • Detachment of Device or Device Component
  • Device Dislodged or Dislocated

Patient

88 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

ALLEGEDLY, PATIENT WHO UNDERWENT SUPERPATH PROSTHESIS ON AUGUST 22 DISLOCATED ON AUGUST 29 AND STEM AND CHANGEABLE NECK WERE DISLOCATED DURING MANUAL HEALING, AND REVISION WAS PERFORMED ON AUGUST 30 IN AN OPEN SURGERY. PHYSICIAN'S FINDINGS: WHETHER THERE ARE PREVIOUS REPORTS OF STEM AND CHANGEABLE NECK DISASSEMBLY. PRODUCT PROBLEM NOTED. CAUSED BURDEN TO THE PATIENT. REQUEST TO DETERMINE THE CAUSE OF THE PROBLEM. THE ABOVE REQUESTS HAVE BEEN RECEIVED. REPORTING PARTY'S FINDINGS AND STATUS OF RESPONSE: IT IS NOT USUAL FOR THE STEM AND CHANGEABLE NECK TO COME OFF BY MANUAL MANIPULATION. (B)(4).

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.