BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION SC LINER SIZE 2 / 10 MM

    MDR report key: 5252970 · Received November 27, 2015

    Report

    Report Number
    3005180920-2015-00294
    Event Type
    Injury
    Date Received
    November 27, 2015
    Date of Event
    October 29, 2015
    Report Date
    February 24, 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 27 JANUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE PREVIOUS REPORTS. ON 03 FEBRUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 IT WAS COMMUNICATED THAT THE EVENT WAS DUE TO A SKIN INFECTION. BATCH REVIEW PERFORMED ON 27 NOVEMBER 2015: LOT 140467: 30 ITEMS MANUFACTURED AND RELEASED ON 06 MARCH 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. TO BE ANALYZED.

    Additional Manufacturer Narrative · 1

    ON 30 NOVEMBER THE R&D PROJECT MANAGER INSPECTED THE RETRIEVED ITEM WITH THE FOLLOWING COMMENTS: THE EXPLANTED PE LINER WAS FOUND INTACT AND NOT WORN OUT, AS EXPECTED AFTER 1 MONTH FROM IMPLANTATION. THE ANTERIOR LIP OF THE CLIPPING SYSTEM WAS FOUND DEFORMED AND DAMAGED. THIS BREAKAGE WAS MOST LIKELY CAUSED DURING THE EXPLANTATION OF THE LINER. NO ELEMENTS THAT COULD CAUSE PATIENT'S PAIN HAVE BEEN FOUND.

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING PAIN AND SWELLING IN THEIR RIGHT. THE SURGEON WASHED OUT THE KNEE AND REPLACED THE GMK REVISION POLY INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE POLY WILL BE RETURNED. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783097 GMK REVISION SC LINER SIZE 2 / 10 MM TIBIAL PE INSERT JWH MEDACTA INTERNATIONAL SA 140467

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Required Intervention