BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/20 MM L E-CROSS

    MDR report key: 19310000 · Received May 14, 2024

    Report

    Report Number
    3005180920-2024-00324
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261952
    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 14 MAY 2024. LOT 2110586: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-SEP-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY (B)(4) OF THE LOT HAS BEEN SOLD.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING MCL INSTABILITY AFTER A PRIMARY TKA AND THE CAUSE IS UNKNOWN. AFTER THE MCL RECONSTRUCTION UTILIZING AN ACHILLES GRAFT, THE POLY NEEDED TO BE DOWNSIZED (FROM 14 TO 13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547265 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/20 MM L E-CROSS KNEE TIBIAL INSERT E-CROSS JWH MEDACTA INTERNATIONAL SA 2110586 07630971261952

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention