BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H COLLARED CEMENTLESS STEM SIZE 1 STD

    MDR report key: 3953162 · Received June 20, 2014

    Report

    Report Number
    3006639916-2014-00075
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON BROACHED TO A SIZE 1 AMISTEM. WHEN THE BROACH WAS REMOVED AND THE IMPLANT WAS IMPLANTED, THE STEM DID NOT FIT SIMILARLY TO THE FIT OF THE BROACH. THE IMPLANT SAT APPROXIMATELY 5M PROTRUDE ABOVE (NOT FLUSH TO THE SURFACE) RELATIVE TO WHERE THE BROACH SAT IN THE FEMUR. IN THE PROCESS OF REMOVING THE SIZE 1 AMISTEM, THE SURGEON FRACTURED THE GREATER TROCHANTER. TO PREVENT ANY OTHER POSSIBLE DAMAGE, THE SURGEON ELECTED TO LEAVE THE IMPLANT TO THE PT. REF MFR REPORT#: 3005180920-2014-00075.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363540 AMISTEM H COLLARED CEMENTLESS STEM SIZE 1 STD FEMORAL COLLARED CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 135064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CODE 01.18.10.101 / LOT UNK.| AMISTEM TRIAL BROACH INTSTRUMENT SIZE 1: