BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C CEMENTED STEM SIZE 4 LAT

    MDR report key: 5580950 · Received April 15, 2016

    Report

    Report Number
    3005180920-2016-00161
    Event Type
    Injury
    Date Received
    April 15, 2016
    Date of Event
    March 18, 2016
    Report Date
    July 12, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 24 MARCH 2016 AND INCLUDES: PRIMARY SURGERY WAS CONDUCTED FROM AROUND 9:00. THIS EVENT WAS OCCURRED AT AROUND 12:00 AND THE SURGEON DECIDED TO CONDUCT REVISION SURGERY IMMEDIATELY, BUT SINCE THE REVISION IMPLANTS AND INSTRUMENTS WERE NOT IN THE HOSPITAL, REVISION SURGERY WAS STARTED AT AROUND EVENING. FINALLY, THE SURGERY WAS FINISHED AT AROUND 22:30. THE SURGERY WAS COMPLETED SUCCESSFULLY. BATCH REVIEW PERFORMED ON 13 APRIL 2016. LOT 152948: 20 ITEMS MANUFACTURED AND RELEASED ON 10 AUGUST 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 15 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 28 JUNE 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    WHEN THE SURGEON IMPACTED TO AMISTEM-C, PATIENT'S FEMORAL BONE CRACKED ABOUT 20CM LONG. THE SURGEON DECIDED TO REPLACE AMISTEM-C STEM WITH OTHER COMPANY'S IMPLANTS ON THE SAME DAY. THE SURGERY WAS PROLONGED ABOUT 12 HOURS. NO PIECES NOR X-RAYS AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236280 AMISTEM C CEMENTED STEM SIZE 4 LAT CEMENTED FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 152948

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention