BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.E0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R E-CROSS

    MDR report key: 18657204 · Received February 7, 2024

    Report

    Report Number
    3005180920-2024-00005
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    December 30, 2023
    Report Date
    January 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261525
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 JANUARY 2024: LOT 2309309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2023. EXPIRATION DATE: 2028-05-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND HALF POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764653 GMK-SPHERE 02.12.E0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R E-CROSS KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 2309309 07630971261525

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention