BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22058931 · Received May 21, 2025

    Report

    Report Number
    3005180920-2025-00430
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 27, 2023
    Report Date
    May 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    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 25-04-2025. LOT 2242046: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-02-2023. EXPIRATION DATE: 2028-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 25-04-2025. GMK-SPHERE 02.12.E0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L E-CROSS (K202022) LOT 2245474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-12-2023. EXPIRATION DATE: 2023-02-06. 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. THE CAUSE IS AN INADVERTENT OVERSIGHT AT THE SURGICAL CENTER. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. DEVICE PRODUCTION HISTORY AND RELATED DOCUMENTATION SHOW NO DEVIATION FROM THE PROCESS.

    Description of Event or Problem · 0

    BACK ON (B)(6) 2023, DURING THE PRIMARY RIGHT KNEE SURGERY, THE SURGEON ACCIDENTLY IMPLANTED A LEFT TIBIAL TRAY AND INSERT INTO THE RIGHT KNEE. AFTER CLOSURE, THE SURGEON OPENED THE PATIENT AGAIN, REMOVED THE TIBIAL TRAY AND INSERT AND IMPLANTED RIGHT SIDE TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. AT ABOUT 1 MONTH FROM THE PRIMARY THE PATIENT DEVELOPED AN INFECTION, AND THE LINER WAS REVISED, MDR 3005180920-2023-00445 WAS FILED. NO FURTHER REVISIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724137 GMK PRIMARY TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L JWH MEDACTA INTERNATIONAL SA 02.07.1205L 2242046 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other