BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM

    MDR report key: 1130479 · Received August 21, 2008

    Report

    Report Number
    1020279-2008-00234
    Event Type
    Injury
    Date Received
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION WAS PERFORMED DUE TO THE DEVICE DISENGAGING, WHEN THE PT HAD A POST-OP FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM FEMORAL HEAD KWY SMITH & NEPHEW, INC., ORTHOPAEDIC DIV NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R