BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 20998825 · Received December 23, 2024

    Report

    Report Number
    3005180920-2024-01123
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    December 6, 2024
    Report Date
    December 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    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 18-DEC-2024. LOT 1907617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2020. EXPIRATION DATE: 2025-01-11. 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. OTHER DEVICES INVOLVED: GMK-HINGE 02.09.0514H FIXED TIBIAL INSERT SIZE 5/14MM (K130299) LOT 2218341: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2022. EXPIRATION DATE: 2027-09-04. 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-HINGE 02.09.4005R FIXED TIBIAL TRAY SIZE 5 R (K130299) LOT 2103424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2021. EXPIRATION DATE: 2026-06-13. 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. 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 PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91300 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE 02.09.2605R FEMORAL COMPONENT SIZE 5 R KRO MEDACTA INTERNATIONAL SA 02.09.2605R 1907617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention