BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM

    MDR report key: 11946023 · Received June 7, 2021

    Report

    Report Number
    3005180920-2021-00478
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817991
    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 14 MAY 2021: LOT 162518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-AUG-2016. EXPIRATION DATE: 2021-07-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE INSERT SEMICONSTRAINED 17MM WITH A 23MM ONE 3 YEARS AND 5 MONTHS AFTER PRIMARY TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844148 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0417SCF 162518 07630030817991

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention