BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 4

    MDR report key: 8631631 · Received May 22, 2019

    Report

    Report Number
    3005180920-2019-00398
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 22, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820847
    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 20 MAY 2019: LOT 167406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2017. EXPIRATION DATE: 2022-01-29. 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 ADDITIONAL IMPLANT INVOLVED IN THE EVENT: GMK-PRIMARY 02.07.0410 APPS FULL-PE PS TIBIAL COMPONENT SIZE 4/10 (K131310), LOT 174589: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUL-2017. EXPIRATION DATE: 2022-07-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT .

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO INFECTION, 4 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE FEMORAL AND THE FULL-PE PS TIBIAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY, THE PATHOGEN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427702 GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 KNEE FEMUR PS CEMENTED JWH MEDACTA INTERNATIONAL SA 167406 07630030820847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention