BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT E-CROSS - CR 2R - 10MM

    MDR report key: 15752411 · Received November 8, 2022

    Report

    Report Number
    3005180920-2022-00848
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 21, 2022
    Report Date
    November 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261266
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 OCTOBER 2022: LOT 2112602: (B)(4) MANUFACTURED AND RELEASED ON 24-NOV-2021. EXPIRATION DATE: 2026-11-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 MONTHS FORM THE PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250811 GMK-SPHERE TIBIAL INSERT E-CROSS - CR 2R - 10MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.E0210CRR 2112602 07630971261266

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention