BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21524142 · Received March 5, 2025

    Report

    Report Number
    3005180920-2025-00152
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    February 11, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 FEBRUARY 2025: LOT 2242793: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2023. EXPIRATION DATE: 2028-JAN-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS ALSO REVISED: GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L (K121416) LOT. 2309761 BATCH REVIEW PERFORMED ON 17 FEBRUARY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2023. EXPIRATION DATE: 2028-JUL-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: THE REPORTED CAUSE WAS METAL ALLERGY WITH NO ALLEGED DEVICE DEFICIENCY OR CONTRIBUTING FACTOR, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD A METAL ALLERGY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 4 MONTHS POST PRIMARY THE SURGEON REVISED ALL COMPONENTS TO SENSITIN COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428164 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIXED CEMENTED SIZE 4 L JWH MEDACTA INTERNATIONAL SA 02.07.1204L 2242793 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention