BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20425986 · Received October 11, 2024

    Report

    Report Number
    3005180920-2024-00809
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261273
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 SEPTEMBER 2024. LOT 2339608: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2023. EXPIRATION DATE: 2028-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION DUE TO KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 7 MONTHS 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
    326092 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE JWH MEDACTA INTERNATIONAL SA 02.12.E0210FL 2339608 07630971261273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention