BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT - FLEX S3L - 12 MM

    MDR report key: 10718014 · Received October 22, 2020

    Report

    Report Number
    3005180920-2020-00734
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826375
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 7 OCTOBER 2020: LOT 1910683: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2020. EXPIRATION DATE: 2025-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 14 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184119 GMK-SPHERE TIBIAL INSERT - FLEX S3L - 12 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0312FL 1910683 07630030826375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention