BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT

    MDR report key: 7057109 · Received November 23, 2017

    Report

    Report Number
    3005180920-2017-00690
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 30 OCTOBER 2017. LOT 111452: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 MAY 2011. EXPIRATION DATE: 2016-04-30. 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. GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 10 MM, CODE 02.07.0310SF, LOT. 102463 (K090988) LOT 102463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 AUGUST 2010. EXPIRATION DATE: 2015-06-30. 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. ON 23 NOVEMBER 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE PICTURE AND COMMENTED AS FOLLOWS: REVISION SURGERY AFTER 5 YEARS FROM PRIMARY IMPLANTATION. AS FOR THE EVENT DESCRIPTION, IT WAS INITIALLY SUPPOSED THAT THE EVENT WAS JUST AN INFECTION THAT COULD BE SOLVED WITH A POLY SWITCH. IT WAS THEN INTRAOPERATIVELY DISCOVERED THAT THE BASEPLATE WAS LOOSE WHEN TRYING TO REMOVE LINER. WHEN THE SURGEON WENT TO REMOVE THE POLY THE WHOLE TIBIAL BASE PLATE DISLODGED FROM THE TIBIA AS THE INFECTION HAS COMPROMISED THE IMPLANT. THE SURGEON COULD SEE SIGNS SHOWING THE IMPLANT HAD BEEN LOOSE FOR A WHILE. FROM THE PICTURE ENCLOSED OF THE EXPLANTED COMPONENT NO RESIDUAL CEMENT CAN BE SEEN ON THE BOTTOM SURFACE OF THE TIBIA BASEPLATE. IT IS SOMETHING USUAL TO BE SEEN AFTER EXPLANTATION SINCE THE CEMENT IS NOT AN ADHESIVE BUT A FILLER. NO OTHER ELEMENTS RELEVANT FOR THE EVENT CAN BE NOTED.

    Description of Event or Problem · 1

    PATIENT HAD ACUTE PRESENTATION OF PAIN AND INFECTION IN KNEE. THE SURGEON WAS EXPECTING TO DO A POLY CHANGE AND A WASH OF THE KNEE. WHEN HE WENT TO REMOVE THE POLY THE WHOLE TIBIAL BASE PLATE DISLODGED FROM THE TIBIA AS THE INFECTION HAS COMPROMISED THE IMPLANT. THE SURGEON COULD SEE SIGNS SHOWING THE IMPLANT HAD BEEN LOOSE FOR A WHILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834357 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 111452 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention