BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    MDR report key: 15778446 · Received November 11, 2022

    Report

    Report Number
    3005180920-2022-00863
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826610
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 NOVEMBER 2022: LOT 2112465: 75 ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2021. EXPIRATION DATE: 2026-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 31 OCTOBER 2022: GMK-SPHERE 02.12.0414FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R (K121416) LOT 2011402: 25 ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2021. EXPIRATION DATE: 2026-02-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND DIFFICULTY AMBULATING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT'S POLY ON THE LEFT AND RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2875555 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L KNEE CEMENTED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0414FL 2112465 07630030826610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention