BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0

    MDR report key: 7421485 · Received April 11, 2018

    Report

    Report Number
    3005180920-2018-00226
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 11, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802607
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 APRIL 2018; LOT 090501/T: (B)(4) ITEM MANUFACTURED AND RELEASED ON 24 JUNE 2013. EXPIRATION DATE: 2018-05-31 NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR STEM LOOSENING. STEM SWAPPED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264902 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 090501/T 07630030802607

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention