BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT

    MDR report key: 6999519 · Received November 3, 2017

    Report

    Report Number
    3005180920-2017-00633
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 3, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 20 OCTOBER 2017 THE MEDICAL AFFAIRS PROVIDED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ONE YEAR AND 7 MONTHS AFTER PRIMARY TKA THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IT WAS IMMEDIATELY REMOVED AND POLYETHYLENE INSERT WAS EXCHANGED. THE CAUSE OF SELF-UNSCREWING OF THE INSERT SCREW IS NOT KNOWN: ONE POSSIBILITY IS INSUFFICIENT TIGHTENING TORQUE BUT OTHER UNKNOWN CONDITIONS MAY ALSO PLAY A ROLE. BATCH REVIEW PERFORMED ON 30 OCTOBER 2017. LOT 141795: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 APRIL 2014. EXPIRATION DATE: 2019-03-31. 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. PRELIMINARY INVESTIGATION BASED ON RADIOGRAPHIC IMAGES AND THE PICTURES OF THE EXPLANTED COMPONENTS, PERFORMED BY R&D PROJECT MANAGER ON 03 NOV 2017: RADIOGRAPHIC IMAGES SHOW THE PRESENCE OF A LOOSENED INSERT SAFETY SCREW OCCURRED 1 YEAR AND 7 MONTHS AFTER PRIMARY SURGERY. THE MOST-LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW WAS INSUFFICIENT TIGHTENING TORQUE. DURING INSPECTION OF EXPLANTED INSERT, SOME DENTS AND SCRATCHES (MAINLY IN THE LATERAL SIDE) HAVE BEEN NOTED ON THE ARTICULAR SURFACE OF THE TIBIAL INSERT. THEY WERE MOST LIKELY CAUSED BY THE SCREW THAT, ONCE OUT FROM ITS SEAT, WAS INTERPOSED BETWEEN THE ARTICULAR SURFACE OF THE FEMORAL COMPONENT AND THE TIBIAL INSERT. AS CONSEQUENCE, THE SCREW LOOKS DAMAGED IN ITS THREADED PART, WITH THREADS PLASTICALLY DEFORMED UNDERGONE TO THE BODY WEIGHT LOAD. IT WAS SO DECIDED TO CHANGE THE LINER AS WELL. IT WAS DEEMED NOT NECESSARY TO REVIEW ANY OTHER COMPONENTS.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE SCREW HAD BACKED OUT OF THE POLY. THE SURGEON REVISED THE POLY AS PLANNED. THE SURGERY WAS COMPETED SUCCESSFULLY. A TORQUE DRIVER WAS NOT USED IN THE PRIMARY. SCREW WAS EXPLANTED BUT NOT REIMPLANTED. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781146 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141795 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention