BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.E0510FR TIBIAL INSERT FIXED SPHERE FLEX #5/10 MM R E-CROSS

    MDR report key: 17788682 · Received September 21, 2023

    Report

    Report Number
    3005180920-2023-00718
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262003
    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 28-AUG-2023. LOT 2219329: 10 ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2022. EXPIRATION DATE: 2027-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE 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
    2053411 GMK-SPHERE 02.12.E0510FR TIBIAL INSERT FIXED SPHERE FLEX #5/10 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2219329 07630971262003

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention