BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS

    MDR report key: 20341723 · Received October 1, 2024

    Report

    Report Number
    3005180920-2024-00786
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    September 4, 2024
    Report Date
    October 1, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262003
    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 11 SEPTEMBER 2024. LOT 2400519: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2024. EXPIRATION DATE: 2029-02-04. 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

    REVISION DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON PREFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27325 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2400519 07630971262003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention