BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23477187 · Received November 5, 2025

    Report

    Report Number
    3005180920-2025-01069
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261761
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 OCTOBER 2025. GMK-SPHERIKA 02.12.E0410FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R (K202022) LOT2503792: 100 ITEMS MANUFACTURED AND RELEASED ON21-MAR-2025. EXPIRATION DATE:05-MAR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 88 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 30 OCTOBER 2025. GMK-SPHERIKA 02.12.E0410FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM (K202022) LOT2501296: 100 ITEMS MANUFACTURED AND RELEASED ON04-MAR-2025. EXPIRATION DATE:17-FEB-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 87 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE 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

    ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY KNEE SURGERY. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASH OUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON UTILIZED THE DOUBLE-DAIR TECHNIQUE, A TWO-STAGE REVISION PROCEDURE FOR TREATING ACUTE PERIPROSTHETIC JOINT INFECTION PERFORMED WITHIN A FEW DAYS. AS PART OF THIS APPROACH, THE TIBIAL INSERT WAS REVISED DURING THE SECOND STAGE ON (B)(6) 2025, AS A PREVENTIVE MEASURE. FINAL INSERT HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491508 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM JWH MEDACTA INTERNATIONAL SA 02.12.E0410FR 2503792 07630971261761

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention