BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM L

    MDR report key: 12743014 · Received November 3, 2021

    Report

    Report Number
    3005180920-2021-00842
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 4, 2021
    Report Date
    November 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862694
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW WAS PERFORMED ON 11 OCTOBER 2021: LOT 189023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DIC-2018. EXPIRATION DATE: 2023-DIC-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    AT 2 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 13 MM TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645135 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0613FL 189023 07630030862694

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention