BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L E-CROSS

    MDR report key: 20028143 · Received August 22, 2024

    Report

    Report Number
    3005180920-2024-00624
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 20, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261914
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JULY 2024 LOT 2241407:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT ABOUT 1 MONTH FORM THE PRIMARY THE SURGEON REVISED THE 14MM POLY WITH A 20MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013108 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2241407 07630971261914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention