BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2669165 · Received July 12, 2012

    Report

    Report Number
    3005180920-2012-00034
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    June 14, 2012
    Report Date
    July 12, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 3 STD - (B)(4) / LOT 110548 ((B)(4) PRODUCED). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THIRTY SEVEN BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP CC LIGHT METAL BACK (NOT REGISTERED IN THE US): CODE 01.26.52MBTL / LOT 104150 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. FIFTY FOUR CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. IT WAS REPORTED THAT THE REVISION SURGERY WAS DUE TO CUP AND STEM MALPOSITIONING AND LEG LENGTH DISCREPANCY: ON THE BASIS OF THE INFORMATION ABOVE, THE REVISION OF THE IMPLANTS IS HIGHLY LIKELY DUE TO A SURGICAL ERROR DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO CUP AND STEM MALPOSITIONING AND LEG LENGTH DISCREPANCY, 13 MONTHS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STANDARD LZO MEDACTA INTERNATIONAL SA 110548

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CERAMIC LINER| VERSAFITCUP CC LIGHT METAL BACK 52| CERAMIC FEMORAL HEADS| ALL NOT REGISTERED IN THE USA