BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM SHELL WITH CLUSTER HOLES

    MDR report key: 3061588 · Received April 11, 2013

    Report

    Report Number
    1822565-2013-00639
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 THE LINER WAS UNABLE TO BE SEATED INTO THE SHELL DUE TO A BROKEN LOCKING RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155431 TM SHELL WITH CLUSTER HOLES LPH ZIMMER, INC. 61561339

    Patients

    Seq Age Sex Outcome Treatment
    1