inforMED
MalfunctionJDK

STYKER BIOPREP BONE PREPARATION KIT

Received Mar 26, 2025 · Event occurred Mar 13, 2025

Report MW5168259 · MDR key 21700577

Device

Generic name

Prosthesis, Hip, Cement Restrictor

Model number

0206-710-000

Patient

73 YR · Female

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Narrative

Description of Event or Problem

THE INSERTER HANDLE IS SQUARE, AND THE FEMUR IS ROUND, SO IT GETS STUCK AND HAS A TENDENCY TO BREAK OFF. WE HAVE RECEIVED NOTICE OF SIX RECENT EVENTS, INCLUDING THE PATIENT EVENT. THIS HAS BEEN REPORTED TO STYKER.