BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 6 / 10 MM

    MDR report key: 6368086 · Received March 1, 2017

    Report

    Report Number
    3005180920-2017-00075
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    January 30, 2017
    Report Date
    March 1, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 FEBRUARY 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION AND COMMENTED AS FOLLOWS: THE FAILURE OF COUPLING ISSUE SEEMS TO BE RELATED TO AN INCORRECT COUPLING ACTIVITY DURING THE SURGERY. BATCH REVIEW PERFORMED ON 28 FEBRUARY 2017. LOT 130448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 FEBRUARY 2015. EXPIRATION DATE: 2019-12-31. 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. GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 6 RIGHT, CODE 02.07.1206R, LOT. 145583 (K090988) BATCH REVIEW PERFORMED ON 01 MARCH 2017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 MARCH 2013. EXPIRATION DATE: 2018-02-28 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

    DURING A REVISION SURGERY ((B)(4)), THE SIZE 6/10MM UC INSERT WOULD NOT SEAT PROPERLY. THE SURGEON USED A SECONDARY INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SUBJECT DEVICE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150085 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 6 / 10 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 130448

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other