BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21261901 · Received January 29, 2025

    Report

    Report Number
    3005180920-2025-00007
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    January 2, 2025
    Report Date
    January 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261327
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 JANUARY 2025. LOT 2012373: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2021. EXPIRATION DATE: 2026-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. 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

    AT ABOUT 10 DAYS AFTER 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
    1818985 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0211FR 2012373 07630971261327

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention