BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED ACETABULAR CUP INSERTER

    MDR report key: 1520194 · Received October 28, 2009

    Report

    Report Number
    MW5013245
    Event Type
    Malfunction
    Date Received
    October 28, 2009
    Date of Event
    October 26, 2009
    Report Date
    October 26, 2009
    Manufacturer
    DEPUY J+J
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THIS LEFT TOTAL HIP REPLACEMENT, THE PLASTIC PIECE OF THE CUP INSERTER INSTRUMENT BROKE WHILE IN USE. ALL PIECES WERE RETRIEVED AND AN X-RAY WAS TAKEN INTRAOP; NO PIECES WERE SEEN ON X-RAY. REP IS AWARE AND WILL TAKE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED ACETABULAR CUP INSERTER LXH DEPUY J+J P00692001

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR