BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R E-CROSS

    MDR report key: 20021770 · Received August 21, 2024

    Report

    Report Number
    3005180920-2024-00662
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 21, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261846
    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 02 AUG 2024 LOT 2310262: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2023. EXPIRATION DATE: 2028-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR.

    Description of Event or Problem · 0

    AT 12 DAYS FROM THE PRIMARY SURGERY, 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
    1128309 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R E-CROSS KNEE E-CROSS TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2310262 07630971261846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention