BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM

    MDR report key: 7302115 · Received February 28, 2018

    Report

    Report Number
    3005180920-2018-00098
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    January 29, 2018
    Report Date
    February 28, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817137
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018. LOT 130441: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MARCH 2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THREE YEARS AND 3 MONTHS AFTER PRIMARY FOR AN INSTABILITY CASE THE SURGEON REVISED THE 12MM INSERT IMPLANTING A 17MM INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148260 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 130441 07630030817137

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention