BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER FEMORAL SEPERATOR

    MDR report key: 3901760 · Received May 2, 2014

    Report

    Report Number
    1822565-2014-00556
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT IN AN ATTEMPT TO REMOVE THE HEAD, THE HEAD DISTRACTOR WAS FULLY IMPACTED WITHOUT SEPARATING THE HEAD FROM THE STEM. THIS CAUSED THE DISTRACTOR TO BECOME STUCK BETWEEN THE STEM AND HEAD. WHILE ATTEMPTING TO GET THE HEAD DISTRACTOR UNSTUCK, THE HUMERAL STEM LOST PRESS-FIT. AS A RESULT, THE STEM, HEAD AND DISTRACTOR WERE ALL REMOVED AS ONE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265822 ZIMMER FEMORAL SEPERATOR HSD ZIMMER, INC. 60635877

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR ZIMMER TRABECULAR METAL HUMERAL STEM| CATALOG #00434211313, LOT #62609535| LOT #62584723| BIGLIANI/FLATOW HUMERAL HEAD,CATALOG #000430205218