BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22269609 · Received June 18, 2025

    Report

    Report Number
    3005180920-2025-00562
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 2 JUNE 2025: LOT 2424462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-01-2025. EXPIRATION DATE: 2030-01-13. 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 IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 2 JUNE 2025: GMK-SPHERIKA 02.12. E0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS (K202022) LOT 2432677: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-DEC-2024. EXPIRATION DATE: 2029-12-08. 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. KA14L FEMORAL COMPONENT SPHERIKA CEMENTED S4+L (K211004) LOT 2427693: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2024. EXPIRATION DATE: 2029-12-01. 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. 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 HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 20 DAYS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705436 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED LEFT, SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.07.1204L 2424462 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention