BEUDAMED
    FDA Adverse Event Other Summary report: N

    KERAMOS HIP

    MDR report key: 2011832 · Received February 24, 2011

    Report

    Report Number
    1644408-2011-00099
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    PMA / PMN Number
    K953510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY -THE HIP WAS UNSTABLE, THE SURGEON REMOVED THE HEAD, LINER AND SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERAMOS HIP POLY LINER KWY ENCORE MEDICAL, L.P. 209422

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B)(4), LOT 472441| (B)(4), LOT 220322K2