BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM SIZE 4 LATERALIZED

    MDR report key: 3913787 · Received June 10, 2014

    Report

    Report Number
    3005180920-2014-00073
    Event Type
    Injury
    Date Received
    June 10, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 4 LAT REF. 01.12.034 / LOT 101076 (35 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. THIRTY-FOUR ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337596 QUADRA H FEMORAL STEM SIZE 4 LATERALIZED FEMORAL CEMENTLESS STEM STD SHORT NECK JDI MEDACTA INTERNATIONAL, SA 101076

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK