BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT INTERFACE SPHERICAL ACETABULAR SHELL

    MDR report key: 178715 · Received July 24, 1998

    Report

    Report Number
    2243265-1998-00029
    Event Type
    Injury
    Date Received
    July 24, 1998
    Date of Event
    March 25, 1998
    Report Date
    July 24, 1998
    Manufacturer
    OSTEONICS CORP.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REFERENCE MFR'S REPORT 2243265-1998-00028. REPORTED REVISION SURGERY TO LEFT HIP DUE TO PAIN AND RADIOGRAPHIC FINDINGS CONSISTENT WITH ACETABULAR OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT INTERFACE SPHERICAL ACETABULAR SHELL Implant ACETABULAR SHELL KWB OSTEONICS CORP. NA 8804X

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention