BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23583091 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01137
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261686
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 OCTOBER 2025. GMK-SPHERE 02.12. E0314FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 14MM (K202022) LOT 2248479: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2023. EXPIRATION DATE: 13-APR-2023. 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 FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON WOULD LIKE TO UPSIZE THE POLY (FROM 14 MM TO 15 OR 16 MM) TO GIVE THE PATIENT MORE STABILITY. A COMPASSIONATE USE CASE IS BEING INITIATED TO REQUEST THESE CUSTOM SIZE INSERTS FOR THE PATIENT. A SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. MORE DETAILS TO FOLLOW ONCE THE SURGERY IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236425 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 14MM JWH MEDACTA INTERNATIONAL SA 02.12.E0314FR 2248479 07630971261686

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other