BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERIKA CEMENTLESS

    MDR report key: 24603548 · Received March 16, 2026

    Report

    Report Number
    3005180920-2026-00218
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 16, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MBH
    UDI-DI
    07630542702532
    PMA / PMN Number
    K223548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 MARCH 2026. GMK-SPHERIKA 02.12.KA165L GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S5L LOT 2432508 (K223548): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2025. EXPIRATION DATE: 23-FEB-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.E0511FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5L - 11MM LOT 2405557 (K202022): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2024. EXPIRATION DATE: 12-MAR-2029. 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

    REVISION SURGERY DUE TO INFECTION ABOUT 7 MONTHS AFTER PRIMARY SURGERY AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT AND INSERT. ANTIBIOTIC SPACERS WERE IMPLANTED UNTIL PERMANENT HARDWARE IS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666667 GMK SPHERIKA CEMENTLESS GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S5L MBH MEDACTA INTERNATIONAL SA 02.12.KA165L 2432508 07630542702532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention