BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2111199 · Received May 26, 2011

    Report

    Report Number
    1644408-2011-00296
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K935263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO PAIN IN THE HIP. THE SURGEON CHANGED FROM A BI-POLAR TO A TOTAL HIP; STM STAYED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP COCR HEAD, NEUTRAL LPH ENCORE MEDICAL, L.P. 53862561

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention