BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM

    MDR report key: 15240571 · Received August 17, 2022

    Report

    Report Number
    3005180920-2022-00616
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 19, 2022
    Report Date
    August 17, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817298
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17-AUGUST-2022. LOT 180467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2018. EXPIRATION DATE: 2023-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2019. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT SEMICONSTRAINED 14MM S3 WITH AN INSERT SEMICONSTRAINED 10MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222376 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0314SCF 180467 07630030817298

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention