BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS

    MDR report key: 18525602 · Received January 17, 2024

    Report

    Report Number
    3005180920-2023-01090
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 28, 2023
    Report Date
    January 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261754
    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 16-JAN-2024. LOT 2247364: 25 ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2023. EXPIRATION DATE: 2028-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY 6 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE INSERT INCREASING THE HEIGHT OF 3 MM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422580 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2247364 07630971261754

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention