BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES

    MDR report key: 1941984 · Received November 2, 2010

    Report

    Report Number
    2648920-2010-00058
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ZIMMER
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 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: DIMENSIONS TAKEN ON THE RETURNED DEVICE WERE FOUND TO BE CONFORMING. AS RETURNED, A SINGLE WIRE IS PROTRUDING APPROX 0.25". THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING TO MFG, INSPECTION, AND PACKAGING SPECIFICATIONS. THE REPORTED MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY IN PREVIOUS TWO YRS ON A SAME OR SIMILAR DEVICE. AS A RESULT, THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING FOR MFRS GUIDANCE DOCUMENT PUBLISHED BY THE FDA IN (B)(6) OF 1997.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SHELL HAD A PORTION OF METAL PROTRUDING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES HIP PROSTHESIS KWB ZIMMER 61066791

    Patients

    Seq Age Sex Outcome Treatment
    1