BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23615351 · Received November 21, 2025

    Report

    Report Number
    3005180920-2025-01177
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261280
    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.E0210FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM (K202022) LOT 2504613: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APR-2025. EXPIRATION DATE: 19-MAR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA02R GMK SPHERIKA FEMORAL COMPONENT S2R CEMENTED (K211004) LOT 2503103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2025. EXPIRATION DATE: 24-FEB-2030. 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 02.07.1202R TIBIAL TRAY FIX CEMENTED S.2R (K090988) LOT 2433245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2025. EXPIRATION DATE: 20-MAR-2030. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. 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 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON IMPLANTED ANTIBIOTIC SPACERS TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076221 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM JWH MEDACTA INTERNATIONAL SA 02.12.E0210FR 2504613 07630971261280

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention