BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT FIXED SIZE 3 / 17 MM STD

    MDR report key: 6224668 · Received January 5, 2017

    Report

    Report Number
    3005180920-2016-00717
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    December 9, 2016
    Report Date
    April 6, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 DECEMBER 2016 THE PATIENT MATCH DEPARTMENT PROVIDED A PLANNING REVIEW OF THIS CASE, STATING AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. NO ERRORS HAVE BEEN FOUND IN ANY STEP. ADDITIONAL INFORMATION RECEIVED ON 03 JANUARY 2017 AND INCLUDES: THE REVISION SURGERY, PREVIOUSLY SCHEDULED FOR (B)(6) 2016, WAS CANCELED. AT THIS TIME, IT IS UNKNOWN WHEN THE SURGEON INTENDS TO REVISE THIS CASE. NOT YET EXPLANTED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 MARCH 2017. LOT 111418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 AUGUST 2011. EXPIRATION DATE: 2016-06-30. 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 INFORMATION RECEIVED ON 07 MARCH 2017 AND INCLUDES: THIS CASE HAS NOT GONE AHEAD YET. THE COMPLAINT WAS CLOSED. IN CASE OF UPDATES, THEY WILL BE TRANSMITTED TO FDA. ON 09 MARCH 2017 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS REPORT AND IN THE INITIAL ONE. ON 10 MARCH 2017 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    REVISION SURGERY SCHEDULED DUE TO KNEE STIFFNESS. THE PATIENT HAS A 17 MM POLYETHYLENE LINER. THE SURGEON PLANS TO PUT IN A 14 MM POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8398 GMK-PRIMARY TIBIAL INSERT FIXED SIZE 3 / 17 MM STD TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 111418

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention