BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 6 ACCOLADE II BROACH

    MDR report key: 21786405 · Received April 7, 2025

    Report

    Report Number
    0002249697-2025-00380
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 7, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K153345
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED.

    Description of Event or Problem · 0

    DURING IMPLANTATION OF ACCOLADE ENDOPROSTHESIS, BROACH BROKE (PIECE CONNECTING BROACH WITH THE HANDLE BROKE TO BE PRECISE) WHILE IT WAS WITHDRAWN FROM THE FEMUR CANAL. WITH THE HELP OF ADDITIONAL ORTHOPEDIC TOOLS (CHISELS, OSTEOTOMES, RASPATORS) THE BROACH WAS RETRIEVED FROM PATIENT'S BODY. IT WAS PROCEDURE OF LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846669 SIZE 6 ACCOLADE II BROACH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 144883

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other