BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23220332 · Received October 6, 2025

    Report

    Report Number
    3005180920-2025-00992
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 SEPT 2025. LOT 172818: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JULY 2017. EXPIRATION DATE: 25-JUNE-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. 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 8 YEARS AND 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION, AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692759 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R JWH MEDACTA INTERNATIONAL SA 02.12.0410FR 172818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention