BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

    MDR report key: 7905433 · Received September 25, 2018

    Report

    Report Number
    3005180920-2018-00725
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    January 30, 2020
    Report Date
    February 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820885
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020: THE PATIENT HAD PERMANENT HARDWARE IMPLANTED AND AN ANTIBIOTIC SPACER REMOVED.

    Description of Event or Problem · 0

    ON (B)(6) 2020: THE PATIENT HAD PERMANENT HARDWARE IMPLANTED AND AN ANTIBIOTIC SPACER REMOVED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 SEPTEMBER 2018; LOT 173696: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 OCTOBER 2017. EXPIRATION DATE: 2022-09-26; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. GMK-PRIMARY REFERENCE 02.07.0610APPS (K131310) FULL-PE PS TIBIAL COMPONENT SIZE 6/10 ; LOT 135913: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MARCH 2014. EXPIRATION DATE: 2019-02-28; 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

    REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION 2 MONTHS AFTER SURGERY (THE PATHOGEN RESULTS ARE NOT AVAILABLE). THE SURGEON WASHED OUT THE KNEE AND REVISED THE FEMUR AND TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748461 GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.07.2206L 173696 07630030820885

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention