BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 R

    MDR report key: 9109179 · Received September 24, 2019

    Report

    Report Number
    3005180920-2019-00814
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 24, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    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 (B)(6) 2019, LOT 092758: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2010. EXPIRATION DATE: 30.11.2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN AND THE CAUSE OF THE PAIN IS MOVED TIBIAL COMPONENT THAT CAME OFF THE BONE, MORE THAN 9 YEARS FROM PRIMARY. THE SURGEON REVISED THE TIBIAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907521 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 R CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 092758 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention