BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 23876945 · Received December 23, 2025

    Report

    Report Number
    3005180920-2025-01309
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 16, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 DECEMBER 2025. GMK-SPHERIKA 02.07.1203R TIBIAL TRAY FIX CEMENTED S.3R (K090988) LOT 2506160: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2025. EXPIRATION DATE: 27-APR-2030. 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.E0310FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 10MM (K202022) LOT 2504616: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2025. EXPIRATION DATE: 01-APR-2030. 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.KA13R GMK SPHERIKA FEMORAL COMPONENT S3+R CEMENTED (K211004) LOT 2503115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-APR-2025. EXPIRATION DATE: 31-MAR-2030. 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.E002RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S2 (K202022) LOT 2506561: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2025. EXPIRATION DATE: 27-APR-2030. 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 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIAL TRAY, INSERT FROM GMK-SPHERIKA TO GMK-REVISION. THE SURGEON ALSO SWAPPED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531905 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIX CEMENTED S.3R JWH MEDACTA INTERNATIONAL SA 02.07.1203R 2506160 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention