BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SYSTEM SHELL

    MDR report key: 2110029 · Received May 17, 2011

    Report

    Report Number
    2648920-2011-00028
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SHELL DID CONTAIN A PROTRUDING WIRE. THE SHELL WAS NOT RETURNED IN THE INITIAL PACKAGING. BY NATURE OF THE MATERIAL, POST-MFG HANDLING HAS THE POTENTIAL TO PULL UP A LOOSE WIRE. POST-MFG HANDLING MAY HAVE PULLED THE WIRE LOOSE IN THIS CASE. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. EVAL: THE MFG RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICE WAS MFG, INSPECTED, AND PACKAGED TO SPEC. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A FIBER METAL WIRE WAS STICKING UP OUT OF THE CUP. THE SURGERY WAS COMPLETED WITH A LARGER CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM SHELL LPH ZIMMER 61612770

    Patients

    Seq Age Sex Outcome Treatment
    1