BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERASENSE FOR STRYKER TRIATHLON SIZE 2 CR

    MDR report key: 8028327 · Received October 31, 2018

    Report

    Report Number
    MW5080984
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 29, 2018
    Manufacturer
    HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ORTHO-SENSOR DID NOT ZERO NOR FUNCTION DURING INTRAOPERATIVE USE. MACHINE SEQUESTERED AND MANUFACTURER NOTIFIED TO REPLACE FAULTY DEVICE AND DIAGNOSE/REPAIR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863139 VERASENSE FOR STRYKER TRIATHLON SIZE 2 CR PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER JWH HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS SYK-TRCR 02

    Patients

    Seq Age Sex Outcome Treatment
    1