BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 14 MM

    MDR report key: 8019246 · Received October 30, 2018

    Report

    Report Number
    3005180920-2018-00844
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 30, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817236
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 OCTOBER 2018 LOT 123067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 NOVEMBER 2012. EXPIRATION DATE:2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT CAME IN COMPLAINING OF INSTABILITY 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT BECAME UNSTABLE OVER TIME. THE SURGEON REVISED A 14MM INSERT FOR A 17MM INSERT SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860731 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 14 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 123067 07630030817236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention