BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 20899856 · Received December 11, 2024

    Report

    Report Number
    3005180920-2024-01069
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825415
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 DECEMBER 2024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2022. EXPIRATION DATE: 2026-03-08. 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. ADDITIONAL IMPLANT REVISED: GMK-HINGE 02.09.0112H FIXED TIBIAL INSERT SIZE 1/12MM (K130299) LOT. 181567 BATCH REVIEW PERFORMED ON 03 DECEMBER 2024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018. EXPIRATION DATE: 2023-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-HINGE 02.09.4001L FIXED TIBIAL TRAY SIZE 1 L (K130299) LOT. 2003416 BATCH REVIEW PERFORMED ON 03 DECEMBER 2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2020. EXPIRATION DATE: 2025-06-02. 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

    THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2021 (COMPETITOR KNEE REVISED, GMK HINGE IMPLANTED). SUBSEQUENTLY, ON (B)(6) 2021, REVISION SURGERY FOR INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. ON (B)(6) 2024, REVISION SURGERY FOR INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT AND TIBIAL TRAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457563 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE FEMORAL COMPONENT SIZE2 L KRO MEDACTA INTERNATIONAL SA 02.09.2602L 2013195 07630030825415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention