BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 23437044 · Received October 31, 2025

    Report

    Report Number
    3005180920-2025-01060
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345716095
    PMA / PMN Number
    K211004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2B WRONG PRODUCT CODE INSERTED IN THE INITIAL MDR: JWL . D2B PRODUCT CODE CORRECTED: JWH.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 OCTOBER 2025: GMK-SPHERIKA 02.12. KA04L GMK SPHERIKA FEMORAL COMPONENT S4L CEMENTED (K211004) LOT 2429610: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2025. EXPIRATION DATE: 2029-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 2430237: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2025. EXPIRATION DATE: 2030-02-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12. E0411FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 11MM (K202022) LOT 2426070: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2024. EXPIRATION DATE: 2029-10-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: A REVISION SURGERY WAS PERFORMED 4 MONTHS AFTER THE IMPLANTATION OF A TKA, DUE TO JOINT INSTABILITY. IN THE LONG-LEG X-RAY, A CLEAR VALGUS ALIGNMENT IS VISIBLE, WHICH RESOLVES IN THE SHORT FIELD X-RAY (PROBABLY THE LONG-LEG X-RAYS WERE TAKEN UNDER WEIGHT-BEARING OR VALGUS STRESS). THIS FINDING SUPPORTS THE REPORTED INSTABILITY, INDICATING MEDIAL COMPARTMENT LAXITY. ADDITIONALLY, THE TIBIAL COMPONENT APPEARED SLIGHTLY ELEVATED ON THE MEDIAL PLATEAU; HOWEVER, IT IS UNCLEAR WHETHER THIS FINDING DEVELOPED AFTER WEIGHT BEARING BEGAN OR WAS ALREADY PRESENT SINCE IMPLANTATION.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 4 MONTHS AFTER THE PRIMARY DUE TO LAXITY. TIBIA, FEMUR, INSERT REVISED SUCCESSFULLY TO SEMI-CONTRAINTED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907404 GMK TOTAL KNEE SYSTEM GMK-SPHERIKA FEMORAL COMPONENT S4L CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.KA04L 2429610 07630345716095

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention