BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C CEMENTED STEM #3 STD

    MDR report key: 4774930 · Received May 13, 2015

    Report

    Report Number
    3005180920-2015-00083
    Event Type
    Injury
    Date Received
    May 13, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103189
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015: LOT 132649: (B)(4) STEMS MANUFACTURED AND RELEASED ON (B)(4) 2013. NO ANOMALIES FOUND. TO DATE, (B)(4) STEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. ON (B)(4) 2015 THE MEDICAL AFFAIRS DIRECTOR CHECKED THE X-RAYS WITH THE FOLLOWING COMMENT: THIS IS A POOR QUALITY X-RAY, I CAN DISCERN NO MAJOR INDICATIONS. THE STEM WAS REPORTED TO BE LOOSE; THIS IS A KNOWN POSSIBLE COMPLICATION OF CEMENTED STEMS, ETIOLOGY UNCERTAIN. NO REFERENCE WAS MADE AS TO THE TYPE OF CEMENT USED OR CEMENTATION METHOD; IN ANY CASE, THERE ARE NO KNOWN CONTRAINDICATIONS TO USE AMISTEMS WITH ANY EXISTING BONE CEMENT AND CEMENTATION METHOD. NO ROOT CAUSE CAN BE IDENTIFIED, NO REASON TO BELIEVE THIS PROBLEM IS DEVICE RELATED. ON (B)(4) 2014 THE R AND D DIRECTOR CHECKED THE PICTURES RECEIVED, WRITING THAT: FROM THE PICTURE THERE IS NOTHING TO BE UNDERLINED.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT. ON (B)(6) 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. REFERENCE #UF/IMPORTER NUMBER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312783 AMISTEM C CEMENTED STEM #3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1