BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 4921074 · Received July 8, 2015

    Report

    Report Number
    4921074
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 8, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT EXPLANT RIGHT SHOULDER FAILED REVERSE PROSTHESIS. TWO OF THE FOUR SCREWS WERE BROKEN PRIOR TO ADMIT FOR REMOVAL OF PROSTHESIS AND PLACEMENT OF ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444154 N/A PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT HSD DEPUY ORTHOPAEDICS INC. DPT502 12 MILLIMETER PRESS-FIT *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR