BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM LEFT

    MDR report key: 5457163 · Received February 24, 2016

    Report

    Report Number
    3005180920-2016-00057
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    January 25, 2016
    Report Date
    May 20, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 FEBRUARY 2016. LOT 120381: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2012. EXPIRATION DATE: 2017-04-30. 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. ON 23 FEBRUARY 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: 1,5 YEARS AFTER PRIMARY TKA A PATIENT COMPLAINED OF KNEE INSTABILITY AND NEW SURGERY WAS PERFORMED, IMPLANTING A THICKER TIBIAL INSERT. BOTH COMPONENTS LOOK CORRECTLY ORIENTED AND MOST PROBABLY THE REASON FOR INSTABILITY SHOULD BE SOUGHT IN SOFT TISSUE DEFICIENCY RATHER THAN IN A FAULT OF THE IMPLANTS. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 21 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THE INITIAL REPORT. ON 04 MAY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF KNEE INSTABILITY. THE SURGEON DECIDED TO REMOVED THE 10 MM INSERT AND PUT IN A 13MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS WILL BE AVAILABLE. THE EXPLANT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115338 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 120381

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention