BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.E0412FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R E-CROSS

    MDR report key: 17867049 · Received October 4, 2023

    Report

    Report Number
    3005180920-2023-00753
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261846
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-SEPT-2023. LOT 2241322: 25 ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY (FROM 12MM TO 10MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486197 GMK-SPHERE 02.12.E0412FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R E-CROSS KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 2241322 07630971261846

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention