BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3080674 · Received April 15, 2013

    Report

    Report Number
    3005180920-2013-00039
    Event Type
    Injury
    Date Received
    April 15, 2013
    Report Date
    July 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 2 LAT - REF. 01.18.142 / LOT 123318 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE X-RAYS THE LEG LOOKS SHORTER THAN WHAT IT SHOULD BE AND THIS IS LIKELY RELATED TO A SURGICAL MISTAKE. FROM THE DATA COLLECTED, WE DO NOT HAVE EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    THE X-RAY TAKEN AFTER THE INCIDENT WERE SUBMITTED TO A SURGEON ACTING AS MEDICAL CONSULTANT FOR MEDACTA. ACCORDING TO HIM THE STEM IS UNDERSIZED, DUE TO THE SHAPE OF PROXIMAL FEMUR AND TO THE SIZE OF STEM THE PRIMARY STABILITY IS ON LEVEL OF NECK RESECTION AND THERE IS NO DISTAL PRESSFIT. ON THE DORSAL NECK REGION THERE IS SOFT BONE AND WITH WEIGHT BEARING A FRACTURE OCCURRED AND THE STEM SUBSIDED. FOR THESE CASES, HE SUGGESTS CEMENTED STEMS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161133 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 2 LAT CEMENTLESS LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1