BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22083876 · Received May 26, 2025

    Report

    Report Number
    3005180920-2025-00474
    Event Type
    Injury
    Date Received
    May 26, 2025
    Date of Event
    May 2, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2B HAS BEEN UPDATED FROM JWK TO JWH.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW: AS INVOLVED LOT IS UNKNOWN NO INVESTIGATION COULD BE PERFORMED. ROOT CAUSE: 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

    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. NO INFORMATION ON PRIMARY SURGERY IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332217 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention