BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 20693481 · Received November 15, 2024

    Report

    Report Number
    3005180920-2024-00945
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825453
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25-OCT-2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2017. EXPIRATION DATE: 2022-04-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: GMK-HINGE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 2237722 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2022. EXPIRATION DATE: 2027-10-25. 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 02.09.0414H FIXED TIBIAL INSERT SIZE 4/14MM(K130299) LOT. 2114873 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2022. EXPIRATION DATE: 2027-01-19. 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 02.09.4004L FIXED TIBIAL TRAY SIZE 4 L (K130299) LOT. 171443 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2017. EXPIRATION DATE:2022-04-10. 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 A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL GMK-HINGE COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196189 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE FEMORAL COMPONENT SIZE 4 L KRO MEDACTA INTERNATIONAL SA 02.09.2604L 168958 07630030825453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention