BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE TIBIAL INSERT SIZE 1/17MM

    MDR report key: 7018030 · Received November 10, 2017

    Report

    Report Number
    3005180920-2017-00652
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 12, 2017
    Report Date
    November 10, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825002
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD A PRIMARY KNEE ON (B)(6) 2014. DURING THE PRIMARY THE TORQUE DRIVER WAS USED. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT TESTED POSITIVE FOR GRANULICATELLA ADIACENS. ON (B)(6) 2016 THE SURGEON REMOVED ALL IMPLANTS. ON (B)(6) 2016 THE SURGEON RE-IMPLANTED MEDACTA COMPONENTS. IN (B)(6) 2017 THE SURGEON DETERMINED THAT THE SCREW AND HINGE MECHANISM DISSOCIATED FROM THE MORSE TAPER OF THE YOKE. THE SURGEON PLANNED TO PERFORM A POLY SWAP ON (B)(6) 2017. BATCH REVIEW PERFORMED ON 09 NOVEMBER 2017. LOT 140422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 FEBRUARY 2014. EXPIRATION DATE: 2019-01-31. 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.

    Description of Event or Problem · 1

    THE PATIENT ORIGINALLY CAME IN DUE TO A CLICKING NOISE IN HER KNEE. THE SURGEON DETERMINED THE SCREW HAD BACKED OUT OF THE YOKE. THE SURGEON PERFORMED A POLY SWAP. THERE WAS NO DAMAGE TO THE SCREW OR THE YOKE. THE SURGEON THREADED THE SCREW BACK INTO THE YOKE. IT WENT IN WITH NO ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802292 GMK-HINGE TIBIAL INSERT SIZE 1/17MM TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 140422 07630030825002

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention