inforMED
MalfunctionJDK

BIOPREP

Received May 6, 2026 · Event occurred Apr 20, 2026

Report 25093303 · MDR key 25093303

Device

Generic name

Prosthesis, Hip, Cement Restrictor

Patient

93 YR · Female

  • Foreign Body In Patient

Narrative

Description of Event or Problem

DURING A HEMIARTHROPLASTY HIP PROCEDURE, BLUE PARTICULATE DEBRIS (¿CHIPS¿) WERE NOTED ON THE STERILE FIELD AFTER USE OF A CEMENT SCRAPER. THE BLUE CEMENT SCRAPER WAS IDENTIFIED AS THE SOURCE OF THE DEBRIS. THE CEMENT SCRAPER WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD. ALL VISIBLE DEBRIS WAS RETRIEVED. A NEW STERILE CEMENT SCRAPER WAS OBTAINED, AND THE PROCEDURE CONTINUED. THE AFFECTED INSTRUMENT WAS ISOLATED FOR FURTHER EVALUATION PER PROTOCOL. NO FURTHER DEBRIS WAS NOTED AFTER REPLACEMENT.