BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL INSERT FLEX #3/12 MM L

    MDR report key: 5250519 · Received November 25, 2015

    Report

    Report Number
    3005180920-2015-00285
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    October 20, 2015
    Report Date
    February 22, 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

    ON (B)(6) 2015 IT WAS COMMUNICATED THAT THE PATHOLOGY RESULTS ARE ENTEROBACTER CLOACAE. BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 120352: (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.

    Additional Manufacturer Narrative · 1

    ON 23 JANUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 25 JANUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    PATIENT HAD PAIN AND SWELLING. THE SURGEON SUSPECTED INFECTION AND DECIDED TO REVISE THE POLY INSERT WHILE WASHING OUT THE KNEE. EXPLANTS WILL NOT BE AVAILABLE FOR ANALYSIS. NO X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780321 GMK SPHERE TIBIAL INSERT FLEX #3/12 MM L PE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 120352

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention