BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5

    MDR report key: 7465425 · Received April 26, 2018

    Report

    Report Number
    0002249697-2018-01251
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    April 2, 2018
    Report Date
    April 26, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. 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. NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED: "[FEMORAL] HEAD WAS NO LONGER ATTACHED. STEINBURG WAS USED TO LOOSEN STEM IN CANAL. ACCOLADE EXTRACTOR WITH SLAP HAMMER ATTACHED. GREATER THAN 10 SWINGS AND STEM WAS OUT. NOTHING UNUSUAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309474 ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 28014602

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R