BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 8555111 · Received April 26, 2019

    Report

    Report Number
    3005180920-2019-00311
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    April 5, 2019
    Report Date
    August 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON JULY 30TH WE RECEIVED THE INFORMATION THAT INITIALLY, THIS COMPLAINT HAS BEEN NOTIFIED DUE TO TIBIAL TRAY LOOSENING, BUT THE AGENT WAS MISINFORMED AND THIS CASE REGARDS INFECTION. ON (B)(6) 2019 THE ANTIBIOTIC SPACER WAS REMOVED AND NEW HARDWARE IMPLANTED. BATCH REVIEW PERFORMED ON 22 JULY 2019: LOT 144874: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07.08.2014. EXPIRATION DATE: 2019-06. 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. LOT 141549: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19.05.2014. EXPIRATION DATE: 2019-04. 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. LOT 140998: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23.06.2014. EXPIRATION DATE: 2019-04. 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. LOT 141001: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14.05.2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY PLANNED AFTER 4 YEARS AND 7 MONTHS DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED ANTIBIOTIC SPACER. AFTER 3 MONTHS FROM THE REVISION SURGERY THE SURGEON REMOVED THE ANTIBIOTIC SPACER AND PERMANENT HARDWARE WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED BY THE SALES AGENT: I STILL DO NOT HAVE A REVISION SURGERY DATE. BATCH REVIEW PERFORMED ON 23 APRIL 2019: LOT 144874: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY TO BE PLANNED DUE TO PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE TIBIAL TRAY 4 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGEON PLANS TO REVISE THE TIBIAL TRAY, POLY AND FEMORAL COMPONENT, THE REVISION SURGERY IS NOT PLANNED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346952 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 144874 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention