inforMED
InjuryLWJ

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

Model number

PHA01232

Catalog 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.