BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L

    MDR report key: 15326895 · Received August 31, 2022

    Report

    Report Number
    3005180920-2022-00665
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 31, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 AUGUST 2022: LOT 2011122: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-DEC-2020. EXPIRATION DATE: 2025-12-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 1 YEAR AND 1 MONTH POST PRIMARY SURGERY THE SURGEON REVISED THE INSERT AND IMPLANTED A THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772800 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 2011122 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention