BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2163698 · Received June 15, 2011

    Report

    Report Number
    1644408-2011-00346
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974093
    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 PT'S HIP WAS INFECTED. THE DOCTOR REMOVED ALL OF OUR IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP HEMISPHERICAL SHELL W/SCREWHOLES LPH ENCORE MEDICAL, L.P. 53837557

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 425-05-007, LOT 966221A| 497-28-000, LOT 53879417| 411-00-035, LOT 583880856| 49938-009, LOT 53882655