BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2682752 · Received July 31, 2012

    Report

    Report Number
    3005180920-2012-00042
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    December 11, 2011
    Report Date
    July 31, 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

    MEDACTA (B)(4) WAS INFORMED ABOUT THE PROBLEM ON (B)(6) 2012 ONLY. DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 2 LAT - (B)(4)/LOT 100546 (46 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. FORTY-ONE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE CAUSE OF THE LOOSENING IS UNK AND WE DO NOT HAVE EVIDENCE THAT THE EVENT IS DEVICE RELATED; STEM LOOSENING IS A KNOWN COMPLICATION OF THR.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING OF THE STEM AMISTEM H (B)(6) MONTHS POST OP. PT HAD PAIN. INFO RECEIVED ON (B)(4) 2012 ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 2 LATERALIZED LZO MEDACTA INTERNATIONAL SA 100546

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention