BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMK TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

    MDR report key: 4747238 · Received April 30, 2015

    Report

    Report Number
    3005180920-2015-00077
    Event Type
    Injury
    Date Received
    April 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/16/2015 THE CASE WAS REVIEWED FROM MY KNEE DEPARTMENT: ALL THE PLANNING STEPS WERE REVIEWED AND NO ANOMALY WAS FOUND. ANYWAY, LOOKING AT THE COMPLAINT WE REALIZE THAT THE SURGEON HAS IMPLANTED A SIZE 3 IMPLANT ON THE FEMUR (WE PROPOSED A SIZE 4). BECAUSE OF THIS, THE CUTS HAD TO BE INCREASED DURING THE SURGERY. WE MADE A POST-OP ANALYSIS: WE OVERLAPPED THE 3D BONE MODEL OF THE TIBIA CUT AND THE FEMUR CUT AND THE X-RAYS WE RECEIVED. WE OVERLAPPED THE 3D BONE MODEL (WITH SIZE 3 IMPLANT) WITH THE X-RAY; THIS SHOWS THAT THE PROSTHESIS HAS BEEN IMPLANTED IN ABOUT 7.0 DEGREES OF VARUS RESPECT TO OUR PLANNING." CLINICAL EVALUATION BY MEDICAL AFFAIRS DIRECTOR ON 07/24/2015 ON THE BASIS OF MY KNEE PLANNING REVIEW: "THE REVIEW CARRIED OUT BY MY KNEE DEPARTMENT CONFIRMS THAT THE IMPLANT HAVE BEEN MISALIGNED COMPARED TO THE PLANNING. QUANTITATIVE ANALYSIS OF DEVIATION HAS BEEN REPORTED. THE MEASURED ANGLES (7 DEGREES FOR FEMUR/ 6 DEGREES FOR TIBIA) ARE NORMALLY CONSIDERED CLINICALLY RELEVANT. ALSO, TIBIAL SLOPE WAS INCREASED OVER THE PLANNED INCLINATION AND FEMORAL SIZE REDUCED, WHICH MEANS ADDITIONAL CUTTING OF FEMORAL BONE. THE FINAL MECHANICAL AXIS WAS DIFFICULT TO DETERMINE, BUT IT IS DIFFERENT FROM THE PLANNED/IDEAL EXPECTATION. WE DO NOT KNOW WHAT ORIGINATED THE SIGNIFICANT DIFFERENCES. IT IS TO BE EXPECTED THAT THE ROOT CAUSE FOR FAILURE WAS MISALIGNMENT BUT WE HAVE NO REPORTS ON PEROPERATIVE PROBLEMS THAT MAY HAVE CAUSED IT". CASE CLOSED AND FINAL REPORT SENT ON 07/30/2015.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04/30/2015: LOT 111454: (B)(4) ITEMS PRODUCED AND RELEASED ON 06/17/2011. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR PROBLEM. LOT 111815: (B)(4) FEMURS PRODUCED AND RELEASED ON 09/22/2011. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR PROBLEM. LOT 100224: (B)(4) ITEMS PRODUCED AND RELEASED ON 03/03/2010. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR PROBLEM. ON 04/30/2015 WE RECEIVED THE CONFIRMATION THAT NO ITEMS WILL BE RECEIVED BACK.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285950 BMK TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT FIXED TIBIAL TRAY JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1