BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R E-CROSS

    MDR report key: 17982848 · Received October 23, 2023

    Report

    Report Number
    3005180920-2023-00827
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262249
    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 04-OCT-2023. LOT 2110596: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2021. EXPIRATION DATE: 2026-09-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 YEAR 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
    985909 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2110596 07630971262249

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention