BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

    MDR report key: 12505718 · Received September 21, 2021

    Report

    Report Number
    3005180920-2021-00756
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816833
    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 27 AUGUST 2021: LOT 2011834: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MARCH-2021. EXPIRATION DATE: 2026-FEB-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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 21 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION: THE PATIENT HAD A PRIMARY AND WAS IMPLANTED WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402538 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0217SCF 2011834 07630030816833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention