BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L

    MDR report key: 14336936 · Received May 9, 2022

    Report

    Report Number
    3005180920-2022-00369
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 9, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826771
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 APRIL 2022. LOT 2112478: 123 ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2021. EXPIRATION DATE: 2026-09-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 13 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243265 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L KNEE TIBIAL INSERT PE JWH MEDACTA INTERNATIONAL SA 02.12.0512FL 2112478 07630030826771

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention