BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM SIZE 5 STANDARD

    MDR report key: 2824140 · Received October 15, 2012

    Report

    Report Number
    3005180920-2012-00065
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 5 STANDARD CEMENTLESS: (B)(4) / LOT 121541 (60 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. TWENTY SIX STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. BIOLOX DELTA CERAMIC HEAD 12/14 0 32 SIZE L (NOT MARKETED IN THE USA, MANUFACTURED BY CERMATEC (B)(4)): (B)(4) / LOT 686097 ((B)(4) HEAD PURCHASED BY MEDACTA): (B)(4) ITEMS BELONGING TO THE LOT PURCHASED HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP CC LINER 0 32/ E: (B)(4) / LOT 122076 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. FIFTY TWO LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP CC LIGHT CUP (NOT MARKETED IN THE USA): (B)(4) / LOT 120577 (60 CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. EIGHTEEN CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE INFECTION IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 1 MONTH POST OP. ALL THE IMPLANTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM SIZE 5 STANDARD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA 121541

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT 122076 (K103352)| VERSAFITCUP CC LINER (B)(4)| SHELL AND CERAMIC HEAD NOT MARKETED IN USA