BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 LAT

    MDR report key: 6215341 · Received December 30, 2016

    Report

    Report Number
    3005180920-2016-00688
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 DECEMBER 2016 THE WASHING AND PACKAGING MANAGER PERFORMED A VISUAL INSPECTION AND COMMENTED AS FOLLOWS: PROBABLY, DURING THE TRANSPORTATION OR IMPLANT STORAGE THE DISTAL FOAM SLIGHTLY DISASSEMBLED FROM THE IMPLANT AND SCRATCHED THE PLASTIC PACKAGING DUE TO THE NATURE OF THE STEM COATING AND BECAUSE IT WAS FREE TO MOVE. BATCH REVIEW PERFORMED ON 27 DECEMBER 2016. LOT 162571:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2016. EXPIRATION DATE: 2021-06-20. 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

    THERE ARE VISIBLE DEBRIS AND SCRATCHES AT THE PACKAGE, SO THE STEM WAS IN CONTACT TO THE PACKAGE AT THE LATERAL SIDE. THE STEM WAS NOT USED AND IT IS AVAILABLE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865796 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 162571

    Patients

    Seq Age Sex Outcome Treatment
    1 Other