BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 23093856 · Received September 19, 2025

    Report

    Report Number
    3005180920-2025-00899
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816505
    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 03 SEPTEMBER 2025: LOT 2244204: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2023. EXPIRATION DATE: 2028-01-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2025: GMK-PRIMARY 02.07.1202L GMK TIBIAL TRAY CEMENTED LEFT S2 (K090988) LOT 2304376: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUNE-2023. EXPIRATION DATE: 2028-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 45 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2025: GMK-PRIMARY 02.07.2002L FEMORAL COMPONENT CEMENTED STD SIZE 2 / LEFT (K090988) LOT 2241588: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2023. EXPIRATION DATE: 2027-12-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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

    AT ABOUT 1 YEAR 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TRAY, FEMORAL COMPONENT, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271050 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL INSERT STD FIXED 10MM, SIZE 2 JWH MEDACTA INTERNATIONAL SA 02.07.0210SF 2244204 07630030816505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention