BEUDAMED
    FDA Adverse Event Other Summary report: N

    RINGLOC ACETABULAR INSERTER

    MDR report key: 612751 · Received July 16, 2004

    Report

    Report Number
    1825034-2004-00063
    Event Type
    Other
    Date Received
    July 16, 2004
    Date of Event
    May 31, 2004
    Report Date
    June 23, 2004
    Manufacturer
    BIOMET, INC.
    Product Code
    KWA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY IN 5/0004, THREADED TIP OF INSERTION INSTRUMENT FRACTURED. TIP SECTION REMAINS IN APICAL HOLE OF THE IMPLANTED SHELL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC ACETABULAR INSERTER INSTRUMENT, INSERTER KWA BIOMET, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other