BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY FEM TRIAL SZ 8R

    MDR report key: 7689253 · Received July 13, 2018

    Report

    Report Number
    MW5078378
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 11, 2018
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS HAVING A RIGHT TOTAL KNEE ARTHROPLASTY WHEN A TRIAL COMPONENT BROKE DURING PLACEMENT. ALL PIECES OF THE BROKEN COMPONENT WERE REVIEWED AND REMOVED FROM THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528348 DEPUY FEM TRIAL SZ 8R PROSTHESIS KNEE JWH DEPUY SYNTHES, INC. D254500728

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR