BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 20808772 · Received November 29, 2024

    Report

    Report Number
    3005180920-2024-00980
    Event Type
    Injury
    Date Received
    November 29, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815768
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 NOVEMBER 2024: LOT 188121: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2018. EXPIRATION DATE: 2023-11-09. 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 COMPONENT REVISED: GMK-REVISION 02.07.0512SCF FIXED TIBIAL INSERT SC SIZE 5/12MM (K103170) LOT 187616: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2018. EXPIRATION DATE: 2023-10-30. 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. CONCLUSIONS: THE SURGEON REVISED LINER AND PATELLA, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT MOBILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A PAINFUL TIBIA AND THE CAUSE OF THE PAINFUL TIBIA IS UNKNOWN. THE SURGEON REVISED ALL THE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA IMPLANT AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445792 GMK PRIMARY TOTAL KNEE SYSTEM RESURFACING PATELLA SIZE 3 JWH MEDACTA INTERNATIONAL SA 02.07.0035RP 188121 07630030815768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention