BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION SC LINER SIZE 4 - 14 MM

    MDR report key: 5240390 · Received November 20, 2015

    Report

    Report Number
    3005180920-2015-00278
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    October 21, 2015
    Report Date
    February 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 20 JANUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON THE SAME DATE, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 NOVEMBER 2015: LOT 140481: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MARCH 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE PATIENT HAD A REVISION OF NON-MEDACTA PRODUCTS. FOLLOWING THIS SURGERY THE PATIENT WAS COMPLAINING OF PAIN AND SWELLING. THE SURGEON SUSPECTED AN INFECTION AND DECIDED TO WASH OUT THE KNEE AND REPLACE THE LINER. THIS REVISION WAS SUCCESSFULLY COMPLETED ON (B)(6) 2015. NO X-RAYS AVAILABLE. THE EXPLANT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769497 GMK REVISION SC LINER SIZE 4 - 14 MM PE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 140481

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention