BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI PRESS-FIT STEM 14MM X 100MM

    MDR report key: 2831060 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02149
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K070095
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR.# 2249697-2012-02148.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT REVISED PREFORMED FOR PAIN IN PROXIMAL TIBIA - LEFT KNEE - STATUS POST LEFT KNEE REVISION (B)(6) 2011. UPON EXPLANTATION OF TIBIAL BASEPLATE AND 14X100 MM STEM, BLACK TISSUE WAS OBSERVED IN TIBIAL CANAL. EXAMINATION OF TIBIAL COMPONENT AND STEM SHOWED BACK FLUID BETWEEN STEM/BASEPLATE JUNCTION. STEM WAS EASILY UNSCREWED FORM BASEPLATE BY HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI PRESS-FIT STEM 14MM X 100MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA M5C13AA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention