BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM

    MDR report key: 8711636 · Received June 19, 2019

    Report

    Report Number
    3005180920-2019-00494
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 22, 2019
    Report Date
    June 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825286
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JUNE 2019: LOT 161843: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 APRIL 2016. EXPIRATION DATE: 2021-04-12. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 THE SURGERY THE SURGEON WAS NOT ABLE TO INSERT THE LINER SCREW. THE SCREW THREAD AND THE SIEGE GOT DAMAGED DURING THE SURGEON INSERTION ATTEMPT. THE SURGEON USED A NEW IMPLANT COMPLETING SUCCESSFULLY THE SURGERY, BUT WITH 10-15 MINUTES OF DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504603 GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM KNEE FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 161843 07630030825286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other