BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23197948 · Received October 2, 2025

    Report

    Report Number
    3005180920-2025-00924
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 2, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 10-09-2025. GMK-SPHERE 02.12.0004R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4R (K121416) LOT. 2249227: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-03-2023. EXPIRATION DATE: 2028-02-24. 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. ADDITIONAL COMPONENT INVOLVED AND REVISED: GMK-SPHERE 02.12.T3I4R GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4R (K121416) LOT. 2248084: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-04-2023 EXPIRATION DATE: 2028-03-25. 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. CONCLUSIONS: 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 1 YEAR AND 11 MONTHS, THE PATIENT CAME IN DUE TO A NICKEL ALLERGY. THE SURGEON REVISED ALL COMPONENTS TO SENSITIN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278336 GMK SPHERE TOTAL KNEE SYSTEM FEMUR SPHERE CEMENTED RIGHT, SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.12.0004R 2249227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention