BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22726922 · Received August 6, 2025

    Report

    Report Number
    3005180920-2025-00766
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    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 30 JULY 2025. GMK-SPHERE 02.07.1203R TIBIAL TRAY FIX CEMENTED S.3R (K090988) LOT. 2303898: 24 ITEMS MANUFACTURED AND RELEASED ON 24 MAY 2023. EXPIRATION DATE: 07-MAY-2028. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES ALSO REVISED: GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED # 3 R (K121416), LOT. 2303685: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 MAY 2023. EXPIRATION DATE: 27 -APRIL -2028. NO ANOMALIES WERE 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.E0310FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 10MM (K202022), LOT. 2307907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MAY 2023. EXPIRATION DATE: 17-APRIL-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. GMK-SPHERE 02.15.E029 MOTO E-CROSS PATELLA Ø29 (K213071) LOT. 2238171: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 NOV 2022. EXPIRATION DATE: 02-NOV-2027. NO ANOMALIES WERE 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: 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 AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364906 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIX CEMENTED S.3R JWH MEDACTA INTERNATIONAL SA 02.07.1203R 2303898 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention