BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVELATION HIP

    MDR report key: 2931659 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00033
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K083651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD A TOTAL HIP IMPLANTED IN (B)(6) 2012. THE PT LATER COMPLAINED OF PAIN AND FELT THE IMPLANT WAS LOOSE. THE SURGEON PLANNED TO REMOVE THE MICROMAX STEM AND REPLACE IT WITH A LIMA REVISION. WHILE REMOVING THE MICROMAX STEM, THE SURGEON NOTICED A BONEY GROWTH WITHIN THE POROUS COATING. THE SURGEON COULD NOT DETERMINE WHERE THE PAIN WAS ORIGINATING FROM; THE STEM WAS IN GOOD CONDITION. THE SURGEON REPLACED THE LIMA STEM WITH A PROXIMAL BODY AND REIMPLANTED THE ORIGINAL 36MM COCR HEAD, AS WELL AS CHANGING THE OFFSET SLEEVE TO NEUTRAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34246 REVELATION HIP REVELATION MICROMAX, STD. NECK LPH ENCORE MEDICAL, L.P. 101G1002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 411-00-035, LOT 903B1063