BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERIKA CEMENTLESS

    MDR report key: 23850108 · Received December 19, 2025

    Report

    Report Number
    3005180920-2025-01279
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 8, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MBH
    UDI-DI
    07630345799340
    PMA / PMN Number
    K223548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 DECEMBER 2025. GMK-SPHERIKA 02.12. KA174L GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S4+L (K223548) LOT. 2504806: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2025, EXPIRATION DATE: 2030-05-07. 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 02.12.3D05L GMK 3DMETAL TIBIAL TRAY SIZE 5L (K221850) LOT. 2345842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2024, EXPIRATION DATE: 2029-02-19. 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. E0510FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5L - 10MM (K202022) LOT. 2426073: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2024, EXPIRATION DATE: 2029-10-07. 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

    FEW DAYS AFTER PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE INSERT, TRAY, AND FEMORAL COMPONENT, OPTING TO USE A CEMENTED OPTION TO HELP WITH INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386464 GMK SPHERIKA CEMENTLESS GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S4+L MBH MEDACTA INTERNATIONAL SA 02.12.KA174L 2504806 07630345799340

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention