BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 1943853 · Received December 22, 2010

    Report

    Report Number
    1644408-2010-00685
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON REMOVED THE KERAMOS LINER AND CERAMIC HEAD. HE REPLACED THEM WITH A HXL KERAMOS LINER AND CERAMIC BIOLEY DELTA OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN LPH ENCORE MEDICAL, L.P. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention