BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/11 MM R

    MDR report key: 10452931 · Received August 26, 2020

    Report

    Report Number
    3005180920-2020-00540
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 24, 2020
    Report Date
    August 26, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862625
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 AUGUST 2020: LOT 1900417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2019. EXPIRATION DATE: 2024-04-06. 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN, 23 DAYS AFTER THE PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921954 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/11 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0411FR 1900417 07630030862625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention