BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20448873 · Received October 15, 2024

    Report

    Report Number
    3005180920-2024-00825
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862588
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 SEPT 2024 GMK-SPHERE 02.12.0311FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM R LOT 2240453: 30 ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 1 YEAR AND 4 MONTHS FROM 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360179 GMK SPHERE TOTAL KNEE SYSTEM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0311FR 2240453 07630030862588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention