BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #3 9MM

    MDR report key: 3808099 · Received May 13, 2014

    Report

    Report Number
    0002249697-2014-01843
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN POLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 1

    BRAND NAME: X3 TRIATHLON CS INSERT #3 9MM. PRODUCT CODE: JWH. CATALOG #: 5531-G-309. LOT #: LAS765. EXPIRATION DATE: 6/30/2012. STERILE LOT #: H6X26. (B)(4). PMA/510(K): K063423. DEVICE MANUFACTURE DATE: 6/1/2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT POLY EXCHANGED DUE TO INSTABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT POLY EXCHANGED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286437 X3 TRIATHLON CS INSERT #3 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LAS765

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention