BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22477786 · Received July 11, 2025

    Report

    Report Number
    3005180920-2025-00665
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    May 16, 2023
    Report Date
    June 24, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    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 30 JUNE 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2022. EXPIRATION DATE: 2027-03-24. 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 DEVICES REVISED: GMK-SPHERE 02.12.0005R SPHERE FEMUR CEMENTED RIGHT S5 (K121416) LOT. 2217020 BATCH REVIEW PERFORMED ON 30 JUNE 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2022. EXPIRATION DATE: 2027-09-16. 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-SPHERE 02.12.0411FR SPHERE INSERT FLEX RIGHT 11MM S4 (K140826) LOT. 2201062 BATCH REVIEW PERFORMED ON 30 JUNE 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-17. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 2 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE PATIENT TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073914 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIX CEMENTED S.4R JWH MEDACTA INTERNATIONAL SA 02.07.1204R 2118043 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention