BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM

    MDR report key: 9075825 · Received September 17, 2019

    Report

    Report Number
    3005180920-2019-00772
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817878
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30-AUGUST-2019: LOT 140481: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO INSTABILITY 3 YEARS AND 8 MONTHS AFTER PRIMARY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA INSERT SEMICONSTRAINED 14MM S4 POLY WITH A MEDACTA INSERT SEMICONSTRAINED 17MM S4 POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873785 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 140481 07630030817878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention