BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2427521 · Received January 11, 2012

    Report

    Report Number
    3005180920-2012-00002
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 11, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW. AMISTEM H FEMORAL STEM SIZE 4 - REF 01.18.134/LOT 103440 (60 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE 49 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED. ONE EVENT CONCERNING THIS LOT WAS ALREADY REPORTED TO FDA WITH THE MDR 2011-00020 ((B)(6) 2011): IT WAS A FEMUR FRACTURE PROBABLY DUE TO A MISTAKE MADE BY THE SURGEON AND THE LOT 103440 WAS FINALLY KEPT IMPLANTED. THE LOOSENING WAS NOTICED DURING A POST-OP CHECK-UP: THE PT COMPLAINED OF THIGH PAIN. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IS HIGHLY UNLIKELY; ASEPTIC LOOSENING IS A KNOWN COMPLICATION OF THE TOTAL HIP REPLACEMENT.

    Description of Event or Problem · 1

    STEM CAME LOOSE: STEM, BALL AND LINER REPLACED. IT WAS AN ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 4 STANDARD LZO MEDACTA INTERNATIONAL SA 103440

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention