BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 4.5

    MDR report key: 3120493 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01716
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE PATIENT KEPT THE EXPLANTED DEVICES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL RECORDS WERE PROVIDED. REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. CHR INDICATED 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 THE STEM LOOSENED. REPLACED WITH A LARGER STEM. ALSO, PUT IN A NEW CUP AND LINER AND REPLACED HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STEM LOOSENED. REPLACED WITH A LARGER STEM. ALSO, PUT IN A NEW CUP AND LINER AND REPLACED HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221663 ACCOLADE 132 SIZE 4.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 37735204

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O| R