BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L

    MDR report key: 16415659 · Received February 22, 2023

    Report

    Report Number
    3005180920-2023-00089
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826948
    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 03-FEB-2023. LOT 2000386: (B)(4) MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-FEB-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM) WITH A THICKER ONE (14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407654 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0610FR 2000386 07630030826948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention