BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND(R) QUADRANT SHELL

    MDR report key: 3381823 · Received October 2, 2013

    Report

    Report Number
    1043534-2013-01702
    Event Type
    Injury
    Date Received
    October 2, 2013
    Report Date
    September 13, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6). THIS IS THE SAME EVENT AS 1043534-2013-01703, 01704.

    Description of Event or Problem · 1

    ALLEGEDLY PER JOURNAL ARTICLE BY BRANDT, ET AL., PROC INST MECH ENG H, 2013. 227(28): P. 833-46, "CLINICAL FAILURE ANALYSIS OF CONTEMPORARY CERAMIC-ON-CERAMIC TOTAL HIP REPLACEMENTS.": ONE PATIENT WITH A TRANSCEND(R) CERAMIC-ON-CERAMIC BEARING WAS REVISED NECK IMPINGEMENT WITH METALLOSIS AT 10.87 YEARS FOLLOW UP. THE AUTHORS FURTHER STATED THAT, "PATIENTS WHO HAD INITIALLY RECEIVED THEIR PRIMARY CC BEARING AT OUR INSTITUTION AND WERE SUBSEQUENTLY REVISED." AND "TAPER MISMATCH BETWEEN THE CERAMIC FEMORAL HEAD AND THE TI ALLOY FEMORAL STEM: TRIDENT (STRYKER, INC.), PINNACLE (DEPUY ORTHOPAEDICS, INC), AND TRANSCEND (WRIGHT MEDICAL TECHNOLOGY, INC.)" NO FURTHER DETAILS OF THIS PATIENT OR REVISION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496856 TRANSCEND(R) QUADRANT SHELL HIP COMPONENT, CODE:LPH LPH WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention