BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 3060829 · Received April 5, 2013

    Report

    Report Number
    1822565-2013-00606
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE LINERS HAD WITNESS MARKS WHERE THE LINER HAD CONTACTED THE SHELL, INDICATING THAT IT HAD BEEN IMPACTED WHILE IT WAS IN A CANTED POSITION. THE RETURNED SHELL WAS MEASURED TO PRINT SPECIFICATIONS. FUNCTIONAL TEST CONFIRMED THAT TWO CERAMIC LINERS WERE ABLE TO BE ASSEMBLED WITH THE RETURNED SHELL. CAUSE CANNOT BE DEFINITIVELY DETERMINED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON IMPACTING THE CERAMIC LINER IT WOULD NOT SEAT PROPERLY. THE SURGEON THEN ATTEMPTED 2 MORE ATTEMPTS. THE SURGEON REMOVED THE CUP AND PLACED A NEW CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139800 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO ZIMMER, INC. 62259695

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR