BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK HINGE FIXED TIBIAL INSERT # 1/10MM

    MDR report key: 5172902 · Received October 24, 2015

    Report

    Report Number
    3005180920-2015-00249
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    September 25, 2015
    Report Date
    January 20, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 23 DEC 2015, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT AND IN THE FOLLOW UP #1.ON 23 DEC 2015, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    SIZES OF 10 MM NOT MARKETED IN THE USA. THE OTHER THICKNESSES ARE CLEARED UNDER K130299. BATCH REVIEW PERFORMED ON 23 OCTOBER 2015: (B)(4). ON (B)(6) 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: IN 3,5 YEARS THE LOCKING SCREW GOT LOOSE AND IS NOW LOCATED, ACCORDING TO XRAYS, IN A POSTERO-MEDIAL POSITION, HAVING MIGRATED CRANIALLY. WE CANNOT STATE THAT NO FURTHER DISPLACEMENT OF THE SCREW WILL TAKE PLACE. THE ACTUAL POSITION IS SUFFICIENTLY AWAY FROM ARTICULATING SURFACES, IN THAT CASE REMOVAL OF THE PROSTHESIS COULD BECOME NECESSARY. PERHAPS THE SURGEON WILL EVALUATE THE POSSIBILITY OF REMOVING THE SCREW THROUGH AN ARTHROSCOPY ACCESS IF THE PATIENT CONDITIONS ALLOW THIS COURSE OF ACTION. NORMALLY SCREWS GET LOOSE BECAUSE THEY HAVE NOT BEEN TIGHTENED PROPERLY, BUT THERE IS NO EVIDENCE THAT THIS IS THE CASE. NO DEFINITE CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    ON 01 DEC 2015 IT WAS COMMUNICATED THAT THE SURGEON REMOVED IN ARTHROSCOPY THE SCREW, THAT WAS NOT BROKEN BUT ONLY LOOSEN. THE SURGEON DECIDED TO KEEP THE IMPLANTS IN PLACE WITHOUT THE SCREW. ON 21 DECEMBER 2015 IT WAS COMMUNICATED THAT THE SCREW IS NOT AVAILABLE FOR EVALUATION BECAUSE IT WAS THROWN AWAY BY THE SURGEON.

    Description of Event or Problem · 1

    UNSCREWING OF THE HINGE TIBIAL INSERT SCREW. REVISION TO BE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705392 GMK HINGE FIXED TIBIAL INSERT # 1/10MM FIXED HINGE TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 111295

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR