BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    MDR report key: 17868926 · Received October 4, 2023

    Report

    Report Number
    3005180920-2023-00758
    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
    07630030826733
    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 12-SEPT-2023: LOT 2011061: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2020. EXPIRATION DATE: 2025-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 12-SEPT-2023. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (D079218) LOT 2119243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2022. EXPIRATION DATE: 2027-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIA AND THE INSERT (FROM 10MM TO 20MM ) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104585 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2011061 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention