BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    MDR report key: 15147155 · Received August 2, 2022

    Report

    Report Number
    3005180920-2022-00575
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    July 6, 2022
    Report Date
    August 2, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    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 13 JULY 2022. LOT 2002756: (B)(4). EXPIRATION DATE: 2025-MAY-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AND 5 MONTHS AFTER PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2081732 GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 2002756 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention