MalfunctionJDK
BIOPREP
Received May 6, 2026 · Event occurred Apr 20, 2026
Report 25093303 · MDR key 25093303
Device
Generic name
Prosthesis, Hip, Cement Restrictor
Manufacturer
Stryker CorporationPatient
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.