BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20462135 · Received October 16, 2024

    Report

    Report Number
    3005180920-2024-00810
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    January 21, 2022
    Report Date
    October 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-SEP-2024: LOT 1910676: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2020. EXPIRATION DATE: 2025-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND TIBIAL TRAY LOOSENING HAS BEEN DETECTED. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL TRAY, INSERT AND RESURFACED THE NATURAL PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353516 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3I4 L JWH MEDACTA INTERNATIONAL SA 02.12.T3I4L 1910676 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention