BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE TIBIAL INSERT - SIZE3 - 12 MM

    MDR report key: 18817511 · Received March 1, 2024

    Report

    Report Number
    3005180920-2024-00074
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 6, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825125
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 FEBRUARY 2024: LOT 1900723: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    DURING A RANDOM MDR CHECK CONDUCTED ON OCTOBER 3, 2024, SOME ERRORS WERE NOTICED. A FOLLOW-UP IS BEING INITIATED TO CORRECT THEM. DATE RECEIVED BY MANUFACTURER 06-FEB-2024 (IT WAS INSERTED ON (B)(6) 2024); M. US CONTACT (IT WAS INSERTED M. AU CONTACT); K NUMBER (IT WAS INSERTED IN DEVICE BLA FIELD).

    Description of Event or Problem · 0

    THE POST SCREW HAD BACKED OUT OF THE POLY. AT 3 YEARS AND 8 MONTHS POST PRIMARY (GMK HINGE IMPLANTED DURING PRIMARY), THE SURGEON REVISED THE PATIENT BY REPLACING THE SCREW AND THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002163 GMK-HINGE TIBIAL INSERT - SIZE3 - 12 MM KNEE TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 1900723 07630030825125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention