BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 23121619 · Received September 23, 2025

    Report

    Report Number
    3005180920-2025-00884
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K211004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2025: GMK-SPHERIKA 02.12.KA05R GMK SPHERIKA FEMORAL COMPONENT S5R CEMENTED (K211004) LOT 2424540: 15 ITEMS MANUFACTURED AND RELEASED ON 26-NOV-2024. EXPIRATION DATE: 2029-NOV-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.E0410FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM (K202022) LOT 2436059: 100 ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2025. EXPIRATION DATE: 2030-JAN-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 82 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.07.1204R TIBIAL TRAY FIX CEMENTED S.4R (K090988) LOT 2433884: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2025. EXPIRATION DATE: 2030-FEB-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 33 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

    THE PATIENT HAD A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196251 GMK TOTAL KNEE SYSTEM GMK SPHERIKA FEMORAL COMPONENT S5R CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.KA05R 2424540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention