BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM

    MDR report key: 5563594 · Received April 8, 2016

    Report

    Report Number
    3005180920-2016-00145
    Event Type
    Malfunction
    Date Received
    April 8, 2016
    Date of Event
    March 9, 2016
    Report Date
    July 6, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K103170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 APRIL 2016. LOT 124307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 DECEMBER 2012. EXPIRATION DATE: 2017-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT, CODE 02.07.0683R, LOT. 122368 (K123721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 OCTOBER 2012. EXPIRATION DATE: 2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 1

    DURING A PRIMARY SURGERY OF THE KNEE, THE SURGEON WAS UNABLE TO ENGAGE THE INSERT WITH THE SET SCREW. THE SALES AGENT HAD A SECOND INSERT AVAILABLE, WHICH WAS USED TO COMPLETE THE SURGERY. THERE WAS A SHORT DELAY IN SURGERY WHEN THE SALES AGENT HAD TO RETRIEVE THE NEW INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS AND X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220020 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 124307

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other