BEUDAMED
    FDA Adverse Event Summary report: N

    OSTEONICS OMNIFIT 10 DEGREE CUP INSERT-SERIES I

    MDR report key: 179257 · Received July 27, 1998

    Report

    Report Number
    2243265-1998-00031
    Date Received
    July 27, 1998
    Manufacturer
    OSTEONICS CORPORATION
    Product Code
    KWB
    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 OF 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 10 DEGREE CUP INSERT-SERIES I Implant ACETABULAR BEARING INSERT KWB OSTEONICS CORPORATION NA 8909T

    Patients

    Seq Age Sex Outcome Treatment
    1 *