BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FERMORAL STEM

    MDR report key: 2758292 · Received August 30, 2012

    Report

    Report Number
    3005180920-2012-00046
    Event Type
    Injury
    Date Received
    August 30, 2012
    Date of Event
    July 10, 2012
    Report Date
    August 30, 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 0 STD - REF (B)(4) / LOT 093008 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECS VALID AT THE TIME OF MFG. FORTY TWO 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 ASEPTIC LOOSENING OF THE STEM AMISTEM H 16 MONTHS AFTER THE PRIMARY SURGERY. PT HAD HIP AND THIGH PAIN. WE WERE INFORMED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FERMORAL STEM FEMORAL STEM SIZE 0 STANDARD LZO MEDACTA INTERNATIONAL SA 093008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention