BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDACTA BIPOLAR HEAD SIZE 22/42

    MDR report key: 3225954 · Received July 10, 2013

    Report

    Report Number
    3005180920-2013-00079
    Event Type
    Injury
    Date Received
    July 10, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    PMA / PMN Number
    K091967
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: MEDACTA BIPOLAR HEAD - REF. (B)(4)/ LOT 102255 ((B)(4) ITEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. FOURTEEN BIPOLAR HEADS BELONGING TO THIS LOT HAVE ALREADY BEEN IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. COCR FEMORAL HEAD (K080885) - REF. (B)(4) / LOT 120542 ((B)(4) HEADS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. EIGHT HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. AMISTEM H FEMORAL STEM CEMENTLESS (K093944) - REF. (B)(4) / LOT 121534 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. SIXTEEN STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. THE STEM WAS NOT REVISED. FROM THE DATA COLLECTED, THE INFECTION OCCURRED IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REFERENCE IMPORTER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315382 MEDACTA BIPOLAR HEAD SIZE 22/42 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1