BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23579958 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01109
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261983
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31-OCT-2025. LOT 2242245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023 EXPIRATION DATE: 2027-DEC-01. 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. ROOT CAUSE: THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 6-MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER (10 TO 13MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644033 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - CR 5R - 10MM JWH MEDACTA INTERNATIONAL SA 02.12.E0510CRR 2242245 07630971261983

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention