BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/10MM

    MDR report key: 18324596 · Received December 14, 2023

    Report

    Report Number
    3005180920-2023-01012
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 14, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818233
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 DECEMBER 2023 LOT 1904803: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JULY-2019. EXPIRATION DATE: 2024-06-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRIMARY WAS A REVISION OF COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768946 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/10MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1904803 07630030818233

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention