BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM

    MDR report key: 5717269 · Received June 10, 2016

    Report

    Report Number
    3005180920-2016-00280
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 13, 2016
    Report Date
    August 4, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 29 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY REPORTED IN THE INITIAL REPORT. ON 02 AUGUST 2016 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 JUNE 2016. (B)(4). ON 10 JUNE 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: SECONDARY STABILIZATION IN A TKA IMPLANTED FIVE MONTHS BEFORE. A THICKER INLAY HAS BEEN IMPLANTED. THIS IS A STANDARD PROCEDURE THAT MAY BE CAUSED BY LIGAMENT LAXITY, SOMETIMES PROGRESSIVE, OR TO AN ATTEMPT BY THE SURGEON TO SPARE AS MUCH TISSUES AS POSSIBLE DURING PRIMARY OPERATION. COMPONENTS LOOK CORRECTLY IMPLANTED AND NO SUBSIDENCE OR MOBILIZATION CAN BE INFERRED FROM THE IMAGES. NO REASON TO SUSPECT THAT THE SECONDARY INTERVENTION WAS DUE TO A DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING INSTABILITY OF THE RIGHT KNEE. THE SURGEON REMOVED THE 12MM UC INSERT AND PUT IN A 17MM UC INSERT. THE SURGEON DID NOT KNOW THE CAUSE OF INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. THE EXPLANT WILL NOT BE RETURNED TO MEDACTA INTERNATIONAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373014 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 121963

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention