BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2413059 · Received January 6, 2012

    Report

    Report Number
    1644408-2011-00698
    Event Type
    Other
    Date Received
    January 6, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD RECURRENT DISLOCATION FROM IMPINGEMENT OF THE FEMORAL NECK ON POSTERIOR/INFERIOR RIM OF THE ACETABULAR LINER. THE SURGEON REPORTED NOTCHING OF THE FEMORAL STEM DUE TO METAL TRANSFER, AS WELL AS THE METAL INSERT "SPINNING" IN THE POLYETHYLENE. THE SURGEON REVISED TO A LARGER CERAMIC HEAD AND POLY LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP COCR HEAD NEUTRAL KWA ENCORE MEDICAL, L.P. 692391

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 499-28-006, LOT 596661