BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2682749 · Received July 31, 2012

    Report

    Report Number
    3005180920-2012-00040
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    May 14, 2012
    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
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON NOTICED THE LOOSENING ON (B)(6) 2012; HE INFORMED MEDACTA'S REPRESENTATIVE IN (B)(6), BUT WE HAD INFO ON FAMILY OF PRODUCT INVOLVED, CODE AND LOT NUMBER ONLY, ON (B)(6) 2012, AFTER SEVERAL REQUESTS. DOCUMENT REVIEW: AMISTEM H FEMORAL SIZE 3 LAT - REF. 01.18.143/LOT 092527 (40 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. ALL THE 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 EVIDENCES THAT THE EVENT IS DEVICE RELATED; STEM LOOSENING IS A KNOWN COMPLICATION OF THR. MOREOVER, THE REVISION SURGERY IS NOT YET DONE NOR PLANNED; AS SOON AS WE HAVE NEWS ABOUT IT, WE WILL SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    PT HAS PAIN. FEMORAL STEM AMISTEM H WAS FOUND LOOSE 25 MONTHS POST PRIMARY SURGERY. THE REVISION SURGERY IS UNDER EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 LATERALIZED LZO MEDACTA INTERNATIONAL SA 092527

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other