BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 23289765 · Received October 15, 2025

    Report

    Report Number
    3005180920-2025-00995
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345716088
    PMA / PMN Number
    K211004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 SEPTEMBER 2025: GMK-SPHERIKA 02.12.KA03R GMK SPHERIKA FEMORAL COMPONENT S3R CEMENTED (K211004) LOT 2430296: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-GEN-2025. EXPIRATION DATE: 19-DEC-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. ADDITIONAL IMPLANT REVISED, BATCH REVIEW PERFORMED ON 26 SEPTEMBER 2025: GMK-SPHERIKA 02.12. E0210FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 10MM (K202022) LOT 2433514: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-GEN-2025. EXPIRATION DATE: 22-DEC-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. CONCLUSIONS: 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

    THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 4 MONTHS AFTER THE PRIMARY THE SURGEON REMOVED THE FEMORAL COMPONENT AND THE INSERT AND PLACED SPACERS WITH ANTIBIOTICS TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647197 GMK TOTAL KNEE SYSTEM FEMORAL COMPONENT SPHERIKA CEMENTED S3R JWH MEDACTA INTERNATIONAL SA 02.12.KA03R 2430296 07630345716088

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention