BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL

    MDR report key: 3420977 · Received October 9, 2013

    Report

    Report Number
    3005180920-2013-00116
    Event Type
    Other
    Date Received
    October 9, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - REF. 01.26.58 MB/ LOT 112859 (29 SHELLS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. TWENTY CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE PROBLEM OCCURRED IS HIGHLY LIKELY DUE TO A SURGICAL MISTAKE AND NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REF. IMP REPORT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511419 VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL ACETABULAR DOUBLE MOBILITY SHELL 58 MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1