BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM L E-CROSS

    MDR report key: 20180516 · Received September 10, 2024

    Report

    Report Number
    3005180920-2024-00705
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261679
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 AUG 2024. LOT 2243371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2023. EXPIRATION DATE: 2028-01-02. 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

    AT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (FROM 14 TO 20 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223533 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM L E-CROSS KNEE TIBIAL INSERT E-CROSS JWH MEDACTA INTERNATIONAL SA 2243371 07630971261679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention