BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 1841638 · Received September 10, 2010

    Report

    Report Number
    1644408-2010-00479
    Event Type
    Other
    Date Received
    September 10, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    PMA / PMN Number
    K953510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - ACETABULAR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP SHELL, BIPOLAR KWY ENCORE MEDICAL, L.P. 54006731

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention 497-28-000, LOT 53989949