BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23349011 · Received October 21, 2025

    Report

    Report Number
    3005180920-2025-00999
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862625
    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 29 SEPTEMBER 2025 GMK-SPHERE 02.12.0411FR GMK-SPHERE TIBIAL INSERT - FLEX S4R - 11 MM (K140826) LOT 2010597: 100 ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2025. EXPIRATION DATE: 20-FEB-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 62 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AFTER 4 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354821 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S4R - 11 MM JWH MEDACTA INTERNATIONAL SA 02.12.0411FR 2010597 07630030862625

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Male Required Intervention