BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8757354 · Received July 3, 2019

    Report

    Report Number
    3005180920-2019-00529
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 26, 2019
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON JULY 3RD 2019: DURING THE REVISION SURGERY THE 12 MM INLAY HAS BEEN CHANGED WITH THE 14 MM INLAY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 JUN 2019: LOT 121963: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2012. EXPIRATION DATE: 2017-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(4) 2019 WE WERE INFORMED OF A REVISION SURGERY PERFORMED AFTER 6 YEARS AND 7 MONTHS (ON (B)(6) 2019) AFTER THE PRIMARY DUE TO KNEE INSTABILITY. THE SURGEON PERFORMED A POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554208 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 121963 07630030817137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention