BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM LEFT

    MDR report key: 6249494 · Received January 13, 2017

    Report

    Report Number
    3005180920-2016-00738
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 16, 2016
    Report Date
    January 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TWO YEARS AFTER PRIMARY TKA, X-RAYS SHOWED THAT THE SECURITY SCREW HOLDING THE TIBIAL INSERT TO THE TIBIAL BASEPLATE BACKED OUT. THE CAUSES FOR THIS EVENT CANNOT BE DETERMINED: IT COULD BE INSUFFICIENT TIGHTENING TORQUE AT INITIAL IMPLANTATION, BUT THIS CANNOT BE DEMONSTRATED. THE SURGEON REPLACED THE INSERT AND APPARENTLY NO DAMAGE WAS FOUND ON REMAINING IMPLANTED COMPONENTS. BATCH REVIEW PERFORMED ON 09 JANUARY 2017. LOT 143374: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JULY 2014. EXPIRATION DATE: 2019-05-31. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON NOTICED THE SCREW BACKED OUT OF THE POLY. THE SURGEON REVISED THE INSERT AND IMPLANTED A 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AVAILABLE, EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31537 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 143374

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention