BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19889666 · Received August 1, 2024

    Report

    Report Number
    3005180920-2024-00576
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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-JUL-2024. LOT 2346356: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2024. EXPIRATION DATE: 2029-01-01. 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 ABOUT 1 WEEK AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217668 GMK-SPHERIKA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 2346356

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention