BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO. 7. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM

    MDR report key: 2911051 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90035
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    September 17, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD¿L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT IS ENROLLED IN THE (B)(4) STUDY AND RECEIVED THEIR STUDY SURGERY ON (B)(6) 2012. THE SITE REPORTED THAT THE SUBJECT EXPERIENCED ¿WOUND RELATED: DEHISCENCE¿ ON (B)(6) 2012 AND THIS IS NOT RELATED TO THE DEVICE. THE EVENT RESULTED IN A TIBIAL INSERT EXCHANGE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4335 NO. 7. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA LE3MHE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention