BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS ACETABULAR SHELL

    MDR report key: 2911661 · Received January 11, 2013

    Report

    Report Number
    1043534-2013-00059
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    November 12, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY PER SCOTT, DF, ET AL., J ARTHROPLASTY. 2012 NOV. 8, "EFFECT OF ZOLEDRONIC ACID ON REDUCING FEMORAL BONE MINERAL DENSITY LOSS FOLLOWING TOTAL HIP ARTHROPLASTY: PRELIMINARY RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL." "AT THE 24-MONTH TIME POINT, A PATIENT IN THE PLACEBO GROUP REQUIRED A HIP REVISION DUE TO IMPLANT BREAKAGE." IT WAS NOT STATED WHICH VARIATION OF THE C+ SHELLS WERE USED. NO DETAILS OF THE REVISIONS WERE STATED. ORIGINAL SURGERIES OCCURRED BETWEEN AUGUST 2005 AND SEPT. 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18297 CONSERVE(R) PLUS ACETABULAR SHELL HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention