BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 25242305 · Received May 21, 2026

    Report

    Report Number
    3005180920-2026-00447
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 21, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040711524
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 21 MAY 2026: GMK-SPHERE 02.12.0722L GMK-SPHERE FEM COMPONENT CEMENTED TINBN COATED 2+L (K202684) LOT: 2411339: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2024. EXPIRATION DATE: 29-SEP-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0212FL GMK-SPHERE TIBIAL INSERT - FLEX S2L - 12 MM (K121416) LOT: 2430367: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2024. EXPIRATION DATE: 25-NOV-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. GMK-SPHERE 02.07.2802L FIXED TIBIAL TRAY SIZE 2 L - TINBN COATING (K202684) LOT: 2413838: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-NOV-2024. EXPIRATION DATE: 31-OCT-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 FOR INFECTION AT ABOUT 7 MONTHS FROM THE PRIMARY. FEMUR, TIBIA, LINER REVISED SUCCESSFULLY AND SPACER IMPLANTED. THE PATELLA IMPLANT WAS NOT REVISED. THE PATIENT HAD PAIN, AND THERE WAS A SUSPECTED LOOSENING, SO THE REVISION WAS PERFORMED FOR THIS REASON, BUT WHEN THE KNEE WAS OPENED, AN INFECTION WAS RECOGNIZED, AND NO DEVICES LOOSEING WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62743 GMK TOTAL KNEE SYSTEM GMK-SPHERE FEM COMPONENT CEMENTED TINBN COATED 2+L JWH MEDACTA INTERNATIONAL SA 02.12.0722L 2411339 07630040711524

    Patients

    Seq Age Sex Outcome Treatment
    1