BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM

    MDR report key: 7605649 · Received June 15, 2018

    Report

    Report Number
    3005180920-2018-00427
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    May 15, 2018
    Report Date
    July 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825194
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 17 AND 18 JUNE 2018: THE TIBIA WAS NOT REPLACED. THE HALF PART OF THE INSERT LOCKING SCREW HAS BEEN TAKING OUT AND LOST. THE NEW INSERT WAS FIXED WITH ITS LOCKING SCREW WITH TORQUE SCREW DRIVER. THE SCREW WAS OUT, STOCK IN THE POLY LINER. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER: REVISION SURGERY AFTER 3 MONTHS FROM PRIMARY SURGERY FOR COMPLETE DISSOCIATION OF THE FEMUR FROM THE TIBIA. IN THE X-RAYS ANALYSIS AND DURING REVISION SURGERY THE HINGE POST LOCKING SCREW WAS FOUND BACKED OUT FROM THE POST AND THE INSERT SCREW WAS FOUND BROKEN. BOTH OF THEM HAVE BEEN RETURNED FOR ANALYSIS. HINGE POST SCREW:THE HINGE POST SECURE SCREW BACKED OUT FROM THE HINGE POST. ITS THREADED PART IS DAMAGED AND PLASTICALLY PRESSED. THE SCREW HAS BEEN PLASTICALLY DEFORMED ONCE, BACKED OUT FROM THE HINGE POST, WAS INTERPOSED BETWEEN THE FEMORAL COMPONENT AND THE TIBIA INSERT AND UNDERWENT TO THE BODY LOAD. DUE TO THIS DEFORMATION, IT IS NO MORE POSSIBLE TO FIX THE SCREW INTO THE HINGE POST. HINGE TIBIA INSERT: ARTICULAR SURFACES OF THE INSERT HAVE BEEN DAMAGED WITH TRACES OF THE THREADED PART OF THE POST-SCREW. ALSO THE HOLE TO HOST THE INSERT SECURE SCREW IS DAMAGED. DUE TO THIS DEFORMATION IT WAS POSSIBLE TO RETAIN THE INSERT SECURE SCREW EVEN IF IT WAS BROKEN. INSERT SECURE SCREW: THE SCREW OF THE INSERT IS BROKEN IN 2 PIECES IN CORRESPONDENCE TO THE THREADED PART OF ITS SHAFT. ONLY ONE PIECE HAS BEEN RETURNED. THE OTHER REMAIN INTO THE BASEPLATE AND WAS REMOVED MANUALLY. HINGE POST: NO ELEMENTS RELEVANT FOR THE EVENT CAN BE NOTED ON THE HINGE POST AND ON ITS THREADED HOLE. IT IS NOT POSSIBLE TO FIND AN EXPLANATION FOR SUCH AN UNLIKELY EVENT. UNSCREWING OF THE HINGE POST SCREW COULD HAVE LED TO DISENGAGEMENT OF THE POST FROM THE FEMORAL COMPONENT. DUE TO THIS DISASSEMBLING, UNPREDICTABLE LOADS COULD HAVE ACTED ON THE INSERT CAUSING INSERT SCREW BREAKAGES AND CONSEQUENT DISLOCATION OF THE INSERT FROM THE BASEPLATE. CAUSE FOR SELF-UNSCREWING OF THE HINGE POST SCREW IS NOT KNOWN. A TORQUE LIMITING SCREWDRIVER (6 NM) IS SUPPLIED AND ITS USE IS MANDATORY IN ORDER TO ACHIEVE THE PROPER MORSE TAPER AXIAL FORCE. THE ONLY CAUSE THAT WE CAN SUPPOSE FOR THIS EVENT IS INSUFFICIENT TIGHTENING TORQUE, EITHER DUE TO A MALFUNCTION OF THE TORQUE LIMITING DEVICE OR TO IMPROPER USE OR TO IMPROPER AXIAL ALIGNMENT OF THE SCREW WITH THE POST DURING TIGHTENING.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JUNE 2018: LOT 163652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2016. EXPIRATION DATE: 2021-07-14 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 12 JUNE 2018: THREE (3) MONTHS AFTER IMPLANTATION OF A CONSTRAINED HINGED SYSTEM IN A SEVERE GENU RECURVATUM, THE PATIENT WAS COMPLAINING OF PAIN AND INSTABILITY DUE TO THE DISENGAGEMENT OF THE INSERT POST EXTENSION FROM THE FEMORAL COMPONENT. THE FIXATION SCREW WAS FOUND LOOSE IN THE JOINT. THE REASON OF SELF UNSCREWING OF THE SCREW IS NOT KNOWN.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO POST SCREW UNSCREWING 3 MONTHS AFTER PRIMARY, DURING THE REVISION SURGERY ALSO THE INLAY LOCKING SCREW WAS FOUND LOOSE IN THE JOINT AND BROKEN. THE PATIENT WAS OPERATED AT THE BEGINNING FOR SEVERE GENU RECURVATUM AND WAS VERY GOOD AFTER SURGERY WITH RETURN TO FULL FUNCTION. IN (B)(6) 2018, THE PATIENT CAME TO HOSPITAL DUE TO PAIN AND INSTABILITY, THE X-RAYS SHOWED A COMPLETE DISSOCIATION OF THE FEMUR FROM THE TIBIA AND THE POST LOCKING SCREW DISENGAGEMENT. DURING THE REVISION SURGERY THE POLY LOCKING SCREW WAS ALSO FOUND BROKEN, MACROSCOPIC EXAM REVILED WEAR OF THE POLY ON ITS ANTERIOR PORTION, THE LINER WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449091 GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 163652 07630030825194

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention