BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 1970249 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00012
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    June 2, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: IMPLANT: AMISTEM H FEMORAL STEM SIZE 7 - REF. (B)(4)/LOT. 093017. INSTRUMENT: AMISTEM TRIAL BROACH SIZE 7 - REF. (B)(4)/LOT. 097638. THE BATCH RECORD REVIEWS OF THE AMISTEM H # 7 LOT 093017 (B)(4) AND OF THE BROACH SIZE #7 LOT 097638 (B)(4) HAVE BEEN CARRIED OUT: ALL THE VALUES WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. IN DETAIL, NO ANOMALIES CONCERNING THE DIMENSIONS OF THE IMPLANTS AND THE TRIAL BROACHES, WERE OBSERVED. ABOUT 16 STEMS OF THE 30 BELONGING TO THE LOT 093017 WERE ALREADY IMPLANTED AND NO OTHER COMPLAINT REGARDING THIS LOT WAS RECEIVED UP TO NOW. THE 3D-VISUALIZATION OF THE TECHNICAL DRAWINGS, TO COMPARE THE DIMENSIONS OF THE STD STEMS AND THE TRIAL BROACHES FROM SIZE 0 TO SIZE 9, HAVE BEEN RE-CARRIED OUT IN R&D DEPARTMENT OF MEDACTA INTL. WITH THE CONFIRMATION THAT THERE ARE NO ANOMALIES. THE RETURNED SET OF BROACHES FROM SIZE 0 TO SIZE 9 WAS MEASURED IN QUALITY CONTROL DEPARTMENT OF MEDACTA INTERNATIONAL AND THE DEVICES RESULTED CONFORMING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. 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

    FRACTURE OF THE GREATER TROCHANTER OCCURRED DURING THE SURGERY. THE FEMUR WAS FIXED WITH A CABLE. THE SURGEON STATED THAT THE AMISTEM #7 WENT LESS DEEP THAN THE TRIAL BROACH #7 INTO THE BONE CANAL. THE SALES AGENT ASSISTING THE SURGERY, REPORTED THAT THE DIFFERENCES BETWEEN THE TRIAL BROACH AND THE IMPLANT WAS A SURGEON'S FEELING. HOWEVER THE INSTRUMENTATION INVOLVED WAS RETURNED FOR A DIMENSIONAL CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 7 STANDARD KWY MEDACTA INTERNATIONAL SA 093017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention TRIAL BROACH SIZE 7: REF. (B)(4)-LOT 097638