BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSENSUS HIP SYSTEM / BIPOLAR SYS.

    MDR report key: 503638 · Received December 9, 2003

    Report

    Report Number
    2952369-2003-00004
    Event Type
    Other
    Date Received
    December 9, 2003
    Date of Event
    November 24, 2003
    Report Date
    December 9, 2003
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    KXA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSENSUS HIP SYSTEM / BIPOLAR SYS. HIP PROSTHESIS - BIPOLAR HEAD KXA HAYES MEDICAL, INC. NA 420020A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other FEMORAL STEM, FEMORAL HEAD, BIPOLAR| INSERT.