BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 23356479 · Received October 22, 2025

    Report

    Report Number
    3005180920-2025-01045
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345729583
    PMA / PMN Number
    K211004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 13 OCTOBER 2025: GMK-SPHERIKA 02.07.12055L GMK FIXED TIBIAL TRAY CEMENTED 5+ LEFT (K211004) LOT 2409717: 30 ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2024. EXPIRATION DATE: 2024-SEP-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED AND REVISED: BATCH REVIEWS PERFORMED ON 13 OCTOBER 2025: GMK-SPHERIKA 02.12.E0510FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5L - 10MM (K202022) LOT 2433530: 50 ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2024. EXPIRATION DATE: 2029-DEC-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEWS PERFORMED ON 13 OCTOBER 2025: GMK-SPHERIKA 02.12.KA07L GMK SPHERIKA FEMORAL COMPONENT S7L CEMENTED (K211004) LOT 2404724: 36 ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2024. EXPIRATION DATE: 2029-JUL-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 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 CAME IN DUE TO PAIN RELATED TO PATELLA BONE TRACKING ISSUES. ADDITIONALLY, THE SURGEON BELIEVES THE PATIENT'S MCL WAS DAMAGED IN A FALL. AT ABOUT 4 MONTHS POST PRIMARY THE SURGEON REVISED THE KNEE TO A HINGE SYSTEM (FEMUR, TIBIA, AND INSERT), RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE MALTRACKING COULD BE RELATED TO THE FALL BUT IT IS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242320 GMK TOTAL KNEE SYSTEM TIBIAL TRAY FIXED CEMENTED SIZE 5+ L JWH MEDACTA INTERNATIONAL SA 02.07.12055L 2409717 07630345729583

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention