BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET

    MDR report key: 6405610 · Received March 10, 2017

    Report

    Report Number
    MW5068438
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 24, 2017
    Report Date
    March 10, 2017
    Manufacturer
    ZIMMER BIOMET
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD SUCCESSFUL COMPREHENSIVE REVERSE SHOULDER SURGERY ON LEFT SHOULDER IN (B)(6) 2011. ON (B)(6) 2017, AS I WAS RAISING MY ARM, SOMETHING POPPED IN MY LEFT SHOULDER CAUSING EXCRUCIATING PAIN AND COMPLETE LOSS OF FUNCTION OF SAID ARM. THE ORIGINAL SURGEON CONDUCTED A SERIES OF X-RAYS WHICH REVEALED THAT THE HUMERAL TRAY (TRUNNION/BASEPLATE) HAD FAILED. THE FAILED PART IS LISTED AS A ZIMMER BIOMET MODEL #115340, WHICH IS CURRENTLY UNDER A CLASS 1 RECALL ALERT. CURRENTLY EXPERIENCING A LOT OF PAIN IF I TRY TO MOVE THE AFFECTED AREA IN ANY WAY!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177790 ZIMMER BIOMET SHOULDER KWS ZIMMER BIOMET #115340

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other ELIQUIS 5 MG| IMPLANT IN RIGHT SHOULDER IN 2003.| LEVOTHYROXINE 100 MCG.| METOPROLOL 25 MG| OTC MEDS: AMIODRAONE 200 MG| RX MEDS: BIOMET COPELAND SHOULDER REPLACEMENT