BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEONICS OMNIFIT HA HIP STEM

    MDR report key: 179242 · Received July 27, 1998

    Report

    Report Number
    2243265-1998-00032
    Event Type
    Injury
    Date Received
    July 27, 1998
    Manufacturer
    OSTEONICS CORPORATION
    Product Code
    KWY
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REFERENCE MFR'S REPORT 2243265-1998-00030. ASEPTIC LOOSENING OFF LEFT TOTAL HIP ARTHROPLASTY WITH EVIDENCE OF POLYETHYLENE WEAR, ASTEOLYSIS PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEONICS OMNIFIT HA HIP STEM Implant FEMORAL STEM KWY OSTEONICS CORPORATION NA 8801BB

    Patients

    Seq Age Sex Outcome Treatment
    1 *