BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM

    MDR report key: 5393896 · Received January 27, 2016

    Report

    Report Number
    3005180920-2016-00002
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    December 28, 2015
    Report Date
    April 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08 JANUARY 2016, THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY ANALYSIS AND COMMENTED AS FOLLOWS: PRIMARY INSERT WAS UC 17 MM REVISED THEN WITH A SC 10 MM. PROBABLY THE INSERT THICKNESS WAS OVERESTIMATED DURING THE PRIMARY SURGERY AND THIS OVERSTUFFING DID NOT ALLOW THE FULL LEG EXTENSION. REVISION FEMORAL COMPONENT SIZE 4: IT WAS THE SAME AS THAT USED IN PRIMARY SURGERY; THIS CONFIRM THAT THERE WAS NOT BONE LOSS. DUE TO THE FACT A CEMENT ISSUE COULD HAVE CAUSED THE IMPLANT LOOSENING TREATED WITH A REVISION SURGERY. SINCE THE PRIMARY SURGERY HAD BEEN PERFORMED USING MYKNEE PATIENT MATCH INSTRUMENTS, THE MYKNEE DEPARTMENT PERFORMED A PATIENT MATCHING PLANNING REVIEW ON 22.JAN.2016 AND COMMENTED AS FOLLOWS: "OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. FURTHERMORE, SINCE THE PECULIARITIES OF THIS PATIENT, THE PLANNING WAS BROADLY DISCUSSED WITH THE SURGEON, AND WE PROCEEDED WITH THE DESIGN OF THE CUTTING BLOCK JUST AFTER A VALIDATION FROM THE SURGEON. RESPECT TO THE VALIDATED REVISION 2 HE DECIDED INTRA OPERATIVELY TO CUT MORE BONE POSTERIORLY, TO IMPLANT A SMALLER SIZE." BATCH REVIEW PERFORMED ON 22 JANUARY 2016. (B)(4). GMK-PRIMARY FEMUR CEMENTED STD 4 NARROW / RIGHT, CODE 02.07.2014R, LOT. 145570 (K122232): (B)(4). ON 27 JANUARY 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: NO PREOPERATIVE X-RAYS ARE AVAILABLE, SO THE PATIENT'S ANATOMY CANNOT BE FULLY EVALUATED. FROM THE SUPPLIED PICTURES, IT SEEMS THAT THIS PATIENT HAS A CYLINDRICAL FEMUR WITH CONDYLES PROTRUDING POSTERIORLY, A RATHER DIFFICULT ANATOMY TO DEAL WITH BECAUSE IT CALLS FOR SOME COMPROMISE. APPARENTLY THERE WAS A NEED TO IMPLANT THE FEMUR IN A RATHER FLEXED ORIENTATION; THIS POSITIONING OF COURSE MAY INDUCE SOME PROBLEMS SUCH AS UNCOMPLETE EXTENSION AND ANTERIOR NOTCHING. IT WAS POSSIBLY AN ATTEMPT BY THE SURGEON TO PERFORM A CONSERVATIVE ARTHROPLASTY WHICH THEN PROVED NOT SATISFACTORY AND A REVISION IMPLANT WAS REQUIRED. THIS MEANT SACRIFICING MORE BONE BUT ACHIEVING BETTER STABILITY WITH THE USE OF INTRAMEDULLARY STEM. THE CAUSE FOR INSUFFICIENT EXTENSION MAY BE LINKED WITH FEMORAL POSITION, IT DOES NOT APPEAR TO BE AN IMPLANT-RELATED PROBLEM.

    Additional Manufacturer Narrative · 1

    ON 21 MARCH 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 24 MARCH 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE SURGEON NOTICED THE PATIENT NEVER REGAINED FULL EXTENSION OF THE KNEE. HER KNEE WAS ALSO LOOSE DURING FLECTION. THE SURGEON DECIDED TO REMOVE THE FEMORAL COMPONENT AND PUT IN A GMK REVISION SIZE 4 PS FEMORAL COMPONENT WITH A GMK REVISION EXTENSION STEM 15MM BY 65MM. THE INSERT WAS EXCHANGED FROM A GMK PRIMARY SIZE 3, 17MM UC INSERT TO A GMK REVISION SIZE 3, 10MM SC INSERT. THE X-RAYS ARE AVAILABLE. THE EXPLANTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53026 GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 131902

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention