BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 1970121 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00025
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    September 14, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 2 - (B)(4)/LOT 101029. THE BATCH RECORD REVIEW OF THE LOT 101029 (60 PIECES PRODUCED) HAS BEEN CARRIED OUT: ALL THE VALUES WERE FOUND TO CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. (B)(4): A REVISION OF THE IMPLANT WAS PERFORMED. THE EVENT WAS THOUGHT TO BE NOT DEVICE RELATED. THE SURGEON EXPRESSED COMPLAINTS CONCERNING THE SHAPE OF THE AMISTEM IMPLANTS AND, FOR THIS REASON, A CLINICAL EXPERT WAS CONTACTED AND HE ANALYZED THE X-RAYS POST OP WITH THE FOLLOWING OPINION: "THE STEM IS IN SLIGHT VARUS AND IN ADDITION IT IS POSSIBLE, THAT ANTETORSION OF THE STEM IS EVENTUALLY NOT CORRECT. IT IS NECESSARY TO DO THE RELEASE AT LEAST TO SUCH AN EXTEND TO BE ABLE TO INTRODUCE THE STEM IN A CORRECT ANTEVERSION. OTHERWISE YOU CAN GET A LITTLE CRACK AT THE CALCAR AND, LATER, A PERIPROSTHETIC FRACTURE. IN OUR EXPERIENCE THE AMISTEM HAS A GOOD SIZE PROXIMALLY AND DISTALLY. UP TO NOW WE HAVEN'T SEEN A PERIPROSTHETIC FRACTURE OR TROCHANTER FRACTURE". THERE ARE NO EVIDENCES THAT THE FRACTURE IS DEVICE RELATED; THIS INJURY IS A KNOWN COMPLICATION OF TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    THE PATIENT HAD A PERIPROSTHETIC FRACTURE DETECTED 8 DAYS AFTER THE SURGERY. AN ADDITIONAL SURGERY WAS DONE TO FIX THE BONE FRACTURE WITH A CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 2 STANDARD LZO MEDACTA INTERNATIONAL SA 101029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention