BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM

    MDR report key: 12687962 · Received October 25, 2021

    Report

    Report Number
    3005180920-2021-00826
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817564
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 1 OCTOBER 2021. LOT 121805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2012. EXPIRATION DATE: 2017-JULY-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY ON (B)(6) 2015. ON (B)(6) 2017, THE PATIENT CAME IN REPORTING INSTABILITY AND NO TRAUMA CAUSED THE INSTABILITY. THE SURGEON REVISED THE INSERT AND SURGERY WAS COMPLETED SUCCESSFULLY. AT 4 YEARS AND 7 MONTHS AFTER, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590903 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0326SCF 121805 07630030817564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention