MalfunctionJDI
CEMENTRALIZER
Received Jun 24, 2026 · Event occurred May 20, 2026
Report 25607158 · MDR key 25607158
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Depuy (ireland)Model number
1376-20-000Catalog number
137620000
Lot number
MF4230
Patient
72 YR · Female
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IN PLACING THE CEMENT RESTRICTOR INTO THE DISTAL CANAL, THE PLACEMENT ROD BROKE OFF AT THE DISTAL TIP. APPROXIMATELY 3" OF THE ROD WAS LEFT IN THE DISTAL CANAL. MANUFACTURER RESPONSE FOR CENTRALIZER HIP STEM DST 11MM_175618_1376-20-000, (BRAND NOT PROVIDED) (PER SITE REPORTER). THE REP WAS IN THE ROOM AT THE TIME OF THE EVENT. NO WRITTEN RESPONSE FROM THE MANUFACTURER.