BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23615333 · Received November 21, 2025

    Report

    Report Number
    3005180920-2025-01155
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 NOV 2025. GMK-SPHERE 02.12.0004L GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4L (K121416) LOT 2004443: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2020. EXPIRATION DATE: 2025-JUL-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.T3I4L GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4L (K121416) LOT 2002832: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2020. EXPIRATION DATE: 2025-JUL-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0413FL GMK-SPHERE TIBIAL INSERT - FLEX S4L - 13 MM (K140826) LOT 2002729: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2020. EXPIRATION DATE: 2025-JUN-11. 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

    AT4 YEARS 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, TIBIA, AND FEMUR TO HINGE TO GIVE THE PATIENT MORE STABILITY. NO ISSUE DETECTED ON THE LIGAMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024002 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4L JWH MEDACTA INTERNATIONAL SA 02.12.0004L 2004443 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention