BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAL 12/14 FEM HEAD 36MM +4

    MDR report key: 3832463 · Received May 27, 2014

    Report

    Report Number
    1020279-2014-00328
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311237 TRIAL 12/14 FEM HEAD 36MM +4 HIP INSTRUMENT KWY SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization