BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

    MDR report key: 12743396 · Received November 3, 2021

    Report

    Report Number
    3005180920-2021-00857
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862618
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 OCTOBER 2021: LOT 2100103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    AT 17 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644715 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0413FL 2100103 07630030862618

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention