BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD

    MDR report key: 6043761 · Received October 20, 2016

    Report

    Report Number
    3005180920-2016-00533
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 20, 2016
    Report Date
    December 7, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 AND INCLUDES: THE REVISION SURGERY WENT SUCCESSFULLY ON (B)(6) 2016. STEM AND HEAD WERE EXPLANTED. STEM LOOSENING WAS CONFIRMED. ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: STEM LOOSENING IN CEMENTLESS THA AFTER 9 YEARS IN A YOUNG MALE PATIENT (ACCORDING TO REPORT: THE STEM LOOSENED STATUS IS NOT OPENLY EVIDENT FROM THE X-RAY). THE STEM LOOKS AS IF IT HAS SUBSIDED LONG TIME BEFORE THE REVISION OPERATION, BUT THERE IS NO CONTROL XRAY AND THE ONLY IMAGE AVAILABLE REPRESENTS ONE HIP ONLY, SO NO JUDGMENT ON POSSIBLE LEG LENGTH DISCREPANCY CAN BE MADE. THE REASONS FOR THE LOOSENING ARE TOTALLY UNKNOWN TO DATE. BATCH REVIEW PERFORMED ON 05 DECEMBER 2016. LOT 062099: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 FEBRUARY 2007. EXPIRATION DATE: 2011-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED ON (B)(6) 2016 DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696716 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 062099

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention