BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23615347 · Received November 21, 2025

    Report

    Report Number
    3005180920-2025-01170
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261457
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 NOVEMBER 2025. GMK-SPHERIKA 02.12.E0217FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2L (K202022) LOT 2338896: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2023. EXPIRATION DATE: 25-SEP-2028. 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. GMK-SPHERIKA 02.12.KA12L GMK SPHERIKA FEMORAL COMPONENT S2+L CEMENTED (K211004) LOT 2424064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2024. EXPIRATION DATE: 04-NOV-2029. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 3 MOUNTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER (FROM 17 MM TO 20 MM) TO GIVE THE PATIENT MORE STABILITY AND REVISED THE FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076217 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2L - 17MM JWH MEDACTA INTERNATIONAL SA 02.12.E0217FL 2338896 07630971261457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention