BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

    MDR report key: 6221207 · Received January 4, 2017

    Report

    Report Number
    3005180920-2016-00704
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 6, 2016
    Report Date
    January 4, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 16 DECEMBER 2016 THE PATIENT MATCH DEPARTMENT PERFORMED A PLANNING REVIEW FOR THIS CASE AND COMMENTED AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. BATCH REVIEW PERFORMED ON 29 DECEMBER 2016. LOT 152355: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2015. EXPIRATION DATE: 2020-05-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF DISCOMFORT. THE DISCOMFORT IS DUE TO TOO MUCH SLOPE IN THE ORIGINAL TIBIA CUT. THE SURGEON REVISED INSERT, FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5380 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 152355

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention