BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L

    MDR report key: 10288183 · Received July 17, 2020

    Report

    Report Number
    3005180920-2020-00437
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 17, 2020
    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 · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 6-JUL-2020 LOT 123023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-OCT-2012. EXPIRATION DATE: 31.08.2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.0310SF TIBIAL INSERT STD FIXED SIZE 3 / 10 MM (K090988) LOT. 113005. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 6-JUL-2020: LOT 113005: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2011. EXPIRATION DATE: 30.09.2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 7 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO AN ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753049 GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2004L 123023 07630030820212

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention