BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15320141 · Received August 30, 2022

    Report

    Report Number
    3005180920-2022-00652
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 1, 2022
    Report Date
    August 30, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 AUGUST 2022: LOT 2108916: (B)(4). EXPIRATION DATE: 2026-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 04 AUGUST 2022: GMK-SPHERE 02.12.0026L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ L (K140826) LOT. 2112039 LOT 2112039: (B)(4). EXPIRATION DATE: 2026-10-06. 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 ABOUT 1 MONTH FROM PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMUR AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148619 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L KNEE FIXED INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 2108916 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention