BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R

    MDR report key: 12742989 · Received November 3, 2021

    Report

    Report Number
    3005180920-2021-00847
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862540
    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 PERFORMED ON 11 OCTOBER 2021: LOT 1910186: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2019. EXPIRATION DATE: 2024-DEC-02. 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

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644256 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R TIBIAL INSERT FIXED SPHERE JWH MEDACTA INTERNATIONAL SA 02.12.0211FR 1910186 07630030862540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention