BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI PRESS-FIT STEM 21MM X 100MM

    MDR report key: 2926063 · Received January 23, 2013

    Report

    Report Number
    0002249697-2013-00176
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K070095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD DEPUY PRIMARY TKA. REVISED TO TRIATHALON TS (B)(6) 2010 DUE TO FAILURE. REVISED (B)(6) 2013 DUE TO COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32483 TRI PRESS-FIT STEM 21MM X 100MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MC4Z6D

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention