inforMED
InjuryLWJ

PROFEMUR® MODULAR FEMORAL NECK

Received Aug 22, 2024

Report 3010536692-2024-00432 · MDR key 20044374

Device

Generic name

Hip Component

Model number

PHA01234

Catalog number

PHA01234

Lot number

887644

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Unspecified Infection
  • Unspecified Infection

Narrative

Additional Manufacturer Narrative

THIS INCIDENT WAS NOT REPORTED ON TIME DUE TO HUMAN ERROR. DURING INITIAL REPORT, NO PART NUMBER WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED AFTERWARDS WITH THE PART NUMBER AND THE REPORT WAS OMITTED BY MISTAKE.

Description of Event or Problem

ALLEGEDLY, THIS PATIENT WAS REVISED DUE TO INFECTION AND NOT A FAILURE OF THE NECK. ALL OF THE COMPONENTS WERE REVISED DUE TO INFECTION, NOT DUE TO COMPONENT FAILURE. IT HAD BEEN IMPLANTED FOR A NUMBER OF YEARS. THE NECK WAS LEFT ATTACHED TO THE REMOVAL DEVICE AND WAS LEFT IN THE INSTRUMENT TRAY AS AN OVERSIGHT FOLLOWING THE END OF THE SURGERY. ADDITIONAL INFORMATION RECEIVED ON 02/01/2024: SHELL AND LINER LOOKED TO BE ANOTHER SUPPLIER.