BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 3 ACCOLADE II 127 DEG

    MDR report key: 3781465 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01565
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K120518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. THE CLINICIAN CONFIRMED THE PERIPROSTHETIC FRACTURE ON THE X-RAY RECEIVED. A DEVICE HISTORY REVIEW INDICATED ALL DEVICES 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, ALTHOUGH IT IS LIKELY THE TRAUMA RESULTED IN THE PERIPROSTHETIC FRACTURE. ADDITIONAL INFORMATION IS NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL WHILE GETTING ON BUS WHICH RESULTED IN A PERI-PROSTHETIC FRACTURE OF LEFT HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL WHILE GETTING ON BUS WHICH RESULTED IN A PERI-PROSTHETIC FRACTURE OF LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260203 SIZE 3 ACCOLADE II 127 DEG IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 38319205

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R