BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22507652 · Received July 15, 2025

    Report

    Report Number
    3005180920-2025-00693
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-JULY-2025. LOT 2112473: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2021. EXPIRATION DATE: 30-SEPT-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT 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 3 YEARS AND 2 MONTHS FROM THE PRIMARY SURGERY, 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
    1535378 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE 02.12.0510FR GMK-SPHERE TIBIAL INSERT - FLEX S5R - 10 MM JWH MEDACTA INTERNATIONAL SA 02.12.0510FR 2112473 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention