BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19390099 · Received May 24, 2024

    Report

    Report Number
    3005180920-2024-00357
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 MAY 2024: LOT 2110139: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEPT-2021. EXPIRATION DATE: 2026-09-12. 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 2 YEARS FROM 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
    2333143 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2110139 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention