BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION FEMORAL WEDGE POSTERIOR SIZE 3/10MM

    MDR report key: 8335137 · Received February 13, 2019

    Report

    Report Number
    3005180920-2019-00051
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 14, 2019
    Report Date
    February 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030822179
    PMA / PMN Number
    K102437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 FEBRUARY 2019: LOT 140518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ON THE 29 JANUARY 2019 THE DEVICE WERE CHECKED AND WE DETECTED A PACKAGING LACKING, THE BRACH RETURNED ONLY THE IMPLANT WITHOUT THE PACKAGING. FROM THE RETURNED DEVICE NO VISUAL INSPECTION IS POSSIBLE BECAUSE THE PACKAGING (THAT IS THE SUBJECT OF THIS COMPLAINT) IS LACKING.

    Description of Event or Problem · 1

    FEMORAL WEDGE POSTERIOR WAS LOOSE IN THE BOX, THE PRIMARY PACKAGING WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127579 GMK-REVISION FEMORAL WEDGE POSTERIOR SIZE 3/10MM FEMORAL WEDGE JWH MEDACTA INTERNATIONAL SA 140518 07630030822179

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other