BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 4 LAT

    MDR report key: 5446936 · Received February 19, 2016

    Report

    Report Number
    3005180920-2016-00054
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    January 22, 2016
    Report Date
    May 20, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 21 APRIL 2016 THE INITIAL REPORTER CONFIRMED THAT NO ADDITIONAL INFORMATION WILL BE PROVIDED BY THE SURGEON ABOUT THIS COMPLAINT. ON 21 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THE INITIAL REPORT. ON 04 MAY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 02FEB2016, IT WAS CONFIRMED THE SURGEON TOLD THAT IT IS NOT POSSIBLE TO GET THE INFORMATION CONCERNING THE HEAD AND THAT THE INFECTION WAS DETECTED DURING THE REVISION SURGERY. TO DATE NO FURTHER INFORMATION WAS RECEIVED CONCERNING THE AVAILABILITY OF THE EXPLANT AND OTHER DETAILS ON THE CASE. BATCH REVIEW PERFORMED ON 16 FEBRUARY 2016. LOT 123816: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 NOVEMBER 2012. EXPIRATION DATE: 2017-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND 1 SIMILAR EVENT HAS BEEN ALREADY REPORTED ON AN ITEM OF THE SAME LOT (MDR 2016-00041). ON 19 FEB 2016 THE MEDICAL AFFAIRS DIRECTOR COMMENTED THE BATCH REVIEW AS FOLLOWING: "IN TERMS OF STATISTICAL RELEVANCE, THE CIRCUMSTANCE THAT TWO INFECTION CASES HAVE BEEN REPORTED CONCERNING PRODUCTS BELONGING TO THE SAME PRODUCTION LOT (OF ABOUT 25-30 UNITS) IS IRRELEVANT. INFECTION IS DEFINITELY MORE CONCERNED BY POSSIBLE PROBLEMS IN THE STERILIZATION LOT, WHICH INCLUDES MANY ITEMS (A COUPLE OF THOUSANDS) AND SEVERAL PRODUCTION LOTS. THEREFORE, THE NUMBERS REPORTED IN YOUR PROBLEM REPORT DO NOT REPRESENT A QUANTITATIVE ANOMALY IN TERMS OF INFECTION RATES."

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION: THE STEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105005 AMISTEM H, HA COATED STEM SIZE 4 LAT FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 123816

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention