BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 2 LAT

    MDR report key: 4217988 · Received July 29, 2014

    Report

    Report Number
    3005180920-2014-00096
    Event Type
    Other
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 2 LAT: (B)(4) / LOT 140023 ((B)(4)): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. AMISTEM H BROACH SIZE 2 - REUSABLE INSTRUMENT: (B)(4) / LOT 1212257 ((B)(4) PRODUCED ON 19 JUNE 2013): AL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED. A FOLLOW UP WILL BE SUBMITTED, IN CASE OF NEW OUTCOMES DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST FOLLOW UP TO THE ORIGINAL MDR 2014-00096.

    Additional Manufacturer Narrative · 1

    THE R&D DIRECTOR CHECKED THE X-RAYS CONFIRMING THE SUBSIDENCE OF THE STEM. THE RETRIED BROACH WAS MEASURED BY QUALITY CONTROL OPERATOR RESULTING TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 1

    DUE TO THE FEMUR NOT SITTING FLUSH DURING INITIAL IMPLANTATION, THE FEMUR HAS SUBSIDED FARTHER CAUSE THE DOCTOR TO REVISE THE FEMUR. THE SURGEON ALSO NOTICED INTRAOPERATIVELY THAT THE FEMUR WAS FRACTURED.

    Description of Event or Problem · 1

    AFTER BROACHING WITH A #2 BROACH, THE SURGEON IMPLANTED A SIZE 2 AMISTEM AND THE STEM SAT ABOUT 4MM LOWER THAN THE FINAL LEVEL OF THE BROACH. TO ACCOMMODATE FOR THE STEM SITTING LOWER, THE SURGEON USED A LARGER HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442921 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 2 LAT FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA 140023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other