BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/11 MM R

    MDR report key: 8764305 · Received July 5, 2019

    Report

    Report Number
    3005180920-2019-00537
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862625
    PMA / PMN Number
    K140826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JUNE 2019: LOT 183058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JULY-2018. EXPIRATION DATE: 2023-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 4 MONTHS FROM THE PRIMARY DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED AN I&D AND REVISED THE INLAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558328 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/11 MM R KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 183058 07630030862625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention