inforMED
InjuryLWJ

PROFEMUR® MODULAR FEMORAL NECK

Received Nov 28, 2023 · Event occurred Nov 9, 2023

Report 3010536692-2023-00219 · MDR key 18216289

Device

Generic name

Hip Component

Model number

PHA01254

Catalog number

PHA01254

Lot number

1492428

Product problems

  • Mechanical Jam
  • Mechanical Jam

Patient

61 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

ALLEGEDLY, UNABLE TO REMOVE THE NECK, THE ENTIRE STEM WAS REMOVED. REPORTING PARTY'S FINDINGS AND RESPONSE STATUS: THERE MAY HAVE BEEN IMPURITIES IN THE NECK-STEM JOINT, OR THE STEM MAY HAVE STUCK DUE TO COLD FLOW. ADDITIONAL INFORMATION RECEIVED ON 2023-11-09: DURING NECK REMOVAL, THE STEM CAME OUT UNINTENTIONALLY (IS IT POSSIBLE THAT THE FIXATION OF THE STEM TO THE BONE WAS INSUFFICIENT). ADDITIONAL INFORMATION RECEIVED ON 2023-11-13: THE PRIMARY REASON FOR REVISION INVOLVED LOOSENING OF A NON-MPO CEMENTED CUP. DURING THIS SURGERY, THE PLAN WAS TO REVISE THE NECK AND HEAD UNLESS INFECTION/LOOSENING OF THE STEM WAS ALSO FOUND. NO INFECTION WAS FOUND, AND ONLY THE NECK WAS TO BE REMOVED. HOWEVER, THE SURGICAL TEAM COULD NOT REMOVE THE NECK FROM THE STEM WHICH RESULTED IN FULL REVISION OF THE FEMORAL STEM AS WELL. JAPAN (B)(4).

Description of Event or Problem

ALLEGEDLY, UNABLE TO REMOVE THE NECK, THE ENTIRE STEM WAS REMOVED. REPORTING PARTY'S FINDINGS AND RESPONSE STATUS: THERE MAY HAVE BEEN IMPURITIES IN THE NECK-STEM JOINT, OR THE STEM MAY HAVE STUCK DUE TO COLD FLOW. ADDITIONAL INFORMATION RECEIVED ON 2023-11-09: DURING NECK REMOVAL, THE STEM CAME OUT UNINTENTIONALLY (IS IT POSSIBLE THAT THE FIXATION OF THE STEM TO THE BONE WAS INSUFFICIENT). ADDITIONAL INFORMATION RECEIVED ON 2023-11-13: THE PRIMARY REASON FOR REVISION INVOLVED LOOSENING OF A NON-MPO CEMENTED CUP. DURING THIS SURGERY, THE PLAN WAS TO REVISE THE NECK AND HEAD UNLESS INFECTION/LOOSENING OF THE STEM WAS ALSO FOUND. NO INFECTION WAS FOUND, AND ONLY THE NECK WAS TO BE REMOVED. HOWEVER, THE SURGICAL TEAM COULD NOT REMOVE THE NECK FROM THE STEM WHICH RESULTED IN FULL REVISION OF THE FEMORAL STEM AS WELL. (B)(4).