BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM

    MDR report key: 14927594 · Received July 6, 2022

    Report

    Report Number
    3005180920-2022-00506
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 6, 2022
    Report Date
    July 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817717
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-JUN-2022 LOT 110875 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2011. EXPIRATION DATE: 2016-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS 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 7 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT, IMPLANTING A THICKER ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367314 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM TIBIAL INSERT UC JWH MEDACTA INTERNATIONAL SA 02.07.0412FUC 110875 07630030817717

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention