BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL BCH FEMORAL HEAD

    MDR report key: 2770798 · Received October 3, 2012

    Report

    Report Number
    1043534-2012-01267
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    PMA / PMN Number
    K072656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: USER ERROR CONTRIBUTED TO EVENT.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE 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 IS THE SAME EVENT AS 1043534-2012-01265, 01266, 01268, 01269.

    Description of Event or Problem · 1

    AS PER: (B)(4). 'EARLY FAILURE OF A CERAMIC-ON-METAL TOTAL HIP ARTHROPLASTY. A CASE REPORT.' ALLEGEDLY A WOMAN (53 YRS OLD AT PRIMARY) REVISED 15 MONTHS POST-OP. PT. HAD GROIN/THIGH PAIN AND INSTABILITY 8 MTHS POST-OP, THEN SUFFERED ANTERIOR DISLOCATION (TREATED WITH CLOSED REDUCTION). MRI SHOWED SIGNS OF ALVAL BURSITIS, SYNOVITIS, EFFUSION, INFLAMMATION. ALL COMPONENTS REVISED, ALVAL CONFIRMED. PT INITIALLY IMPLANTED WITH DYNASTY CERAMIC-ON-METAL ARTICULATION, TI MOD NECK, CEMENTLESS PROFEMUR STEM (BRAND NOT SPECIFIED, POSSIBLY RENAISSANCE OR LX). ARTICULATION USED NOT INDICATED FOR US IN THE US (CERAMIC HEAD ON METAL LINER). AUTHORS' WEAR ANALYSIS SHOWED EDGE-LOADING WEAR ON COCR LINER, NO WEAR ON CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL BCH FEMORAL HEAD HIP COMPONENT, CODE:LZO LZO WRIGHT MEDICAL TECHNOLOGY, INC. 048462181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention