BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 24700708 · Received March 26, 2026

    Report

    Report Number
    3005180920-2026-00267
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820250
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 MARCH 2026: GMK-PRIMARY 02.07.2006L FEMORAL COMPONENT CEMENTED STD SIZE 6 / LEFT (K090988) LOT 103706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-DEC-2010. EXPIRATION DATE: 30-NOV-2015. 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-PRIMARY 02.07.1206L TIBIAL TRAY FIX CEMENTED S.6L (K090988) LOT 103875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2010. EXPIRATION DATE: 30-NOV-2015. 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-PRIMARY 02.07.0610FUC TIBIAL INSERT U.C. FIX S.6 / 10 MM (K090988) LOT 092743: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2009. EXPIRATION DATE: 31-OCT-2014. 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-PRIMARY 02.07.0035RP PATELLA RESURFACING S.3 (NEW GENERATION) (K090988) LOT 103886: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2011. EXPIRATION DATE: 30-NOV-2015. 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. ROOT CAUSE: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 15 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO A TOTAL KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA PRODUCTS FROM THE PRIMARY SURGERY TO COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766752 GMK PRIMARY TOTAL KNEE SYSTEM FEMORAL COMPONENT CEMENTED STD SIZE6 / LEFT JWH MEDACTA INTERNATIONAL SA 02.07.2006L 103706 07630030820250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention