BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L

    MDR report key: 14427349 · Received May 18, 2022

    Report

    Report Number
    3005180920-2022-00379
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 17, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820212
    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 25 APRIL 2022: LOT 103136: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2010. EXPIRATION DATE: 2015-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-JAN-2018. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.0412FUC TIBIAL INSERT UC FIXED SIZE 4 / 12 MM (K090988) LOT. 091786. BATCH REVIEW PERFORMED ON 25 APRIL 2022: LOT 091786: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2009. EXPIRATION DATE: 2014-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-JAN-2018.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. AT 11 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON REVISED THE FEMUR AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605899 GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2004L 103136 07630030820212

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention