BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM

    MDR report key: 912476 · Received September 14, 2007

    Report

    Report Number
    1020279-2007-00218
    Event Type
    Injury
    Date Received
    September 14, 2007
    Report Date
    August 21, 2007
    Manufacturer
    SMITH & NEPHEW, INC.,/ORTHOPAEDIC DIV.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM FEMORAL HEAD KWY SMITH & NEPHEW, INC.,/ORTHOPAEDIC DIV. NA 06MM05179

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R BIPOLAR SHELL| LOT #05BM07971| CATALOG #71302808