BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22027784 · Received May 15, 2025

    Report

    Report Number
    3005180920-2025-00443
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 15, 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 02-MAY-2025 LOT 2403164: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2024. EXPIRATION DATE: 17-APR-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 COMPONENTS INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON 02-MAY-2025. GMK-SPHERIKA 02.12. E003RP PATELLA RESURFACING SIZE 3 E-CROSS (K202022) LOT 2347637: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2024. EXPIRATION DATE: 12-FEB-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. GMK-SPHERIKA 02.12. KA06L FEMORAL COMPONENT SPHERIKA CEMENTED S6L (K211004) LOT 2338093: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2024. EXPIRATION DATE: 27-JAN-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. GMK-SPHERIKA 02.12.E0517FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 MM L E-CROSS (K202022) LOT 2243430: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2023. EXPIRATION DATE: 04-JAN-2028. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER. PRESENTLY, ON (B)(6) 2025, THE PATIENT WAS REPORTING DISCOMFORT AND THE INABILITY TO GET FULL FLEXION. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED SUCCESSFULLY COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884883 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED LEFT, SIZE 5 JWH MEDACTA INTERNATIONAL SA 2403164 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention