BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL

    MDR report key: 3183964 · Received June 12, 2013

    Report

    Report Number
    3005180920-2013-00065
    Event Type
    Injury
    Date Received
    June 12, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K083116
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - REF. 01.26.56MB / LOT 113197 (38 SHELLS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. THIRTY SEVEN CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. VERSAFITCUP DOUBLE MOBILITY HC LINER (B)(4) - REF. 01.26.2856MHC / LOT 112901 (44 LINERS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. FORTY LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. MECTACER BIOLOX FORTE BALL HEAD (B)(4) - REF. 38.39.7175.255.00 / LOT 113521 (30 HEADS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. ALL THE HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. AMISTEM H FEMORAL STEM CEMENTLESS ((B)(4) - REF. 01.18.137 / LOT 112200 (41 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. TWENTY FIVE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. FROM THE DATA COLLECTED, THE INFECTION OCCURRED IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267505 VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL ACETABULAR DOUBLE MOBILITY SHELL LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1