BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM SIZE 2 STANDARD

    MDR report key: 4297202 · Received November 13, 2014

    Report

    Report Number
    3005180920-2014-00149
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 14, 2014
    Report Date
    November 13, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 2 STD, REF 01.12.022, LOT NUMBER 051322 ((B)(4) STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. ALL THE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733874 QUADRA H FEMORAL STEM SIZE 2 STANDARD FEMORAL CEMENTLESS STEM STD JDI MEDACTA INTERNATIONAL, SA 051322

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention