BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 7 ACCOLADE II 127 DEG

    MDR report key: 3233083 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02359
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K120578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. H3 OTHER TEXT : NOT RETURNED

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A SIZE 7 ACCOLADE II 127 DEG WAS REPORTED. THE EVENT WAS NOT CONFIRMED. NOT PERFORMED AS NO DEVICES WERE RETURNED FOR EVALUATION. MEDICAL EVALUATION NOT PERFORMED AS INSUFFICIENT MEDICAL RECORDS WERE RECEIVED. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS REPAIRING A PERI PROSTHETIC FRACTURE WITH STRYKER TOTAL HIP. THE SURGEON USED DALL MILES CABLES AND PLATED THE FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS REPAIRING A PERI PROSTHETIC FRACTURE WITH STRYKER TOTAL HIP. THE SURGEON USED DALL MILES CABLES AND PLATED THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333355 SIZE 7 ACCOLADE II 127 DEG IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 43059604

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R