BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS

    MDR report key: 1720100 · Received June 11, 2010

    Report

    Report Number
    1043534-2010-00156
    Event Type
    Injury
    Date Received
    June 11, 2010
    Report Date
    December 29, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT HISTORY REVIEWED. ANALYSIS SHOWS NO TREND FOR ITEM/LOT. PRODUCT WAS NOT RETURNED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ALTHOUGH ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ASSIGNED CONTACT PERSON, NO RESPONSE HAS BEEN RECEIVED. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THE ARTICLE WAS PUBLISHED IN THE UNITED KINGDOM.

    Description of Event or Problem · 1

    PER ARTICLE "RISK FACTORS FOR INFLAMMATORY PSEUDOTUMOUR FORMATION FOLLOWING HIP RESURFACING", IN THE JOURNAL OF BONE AND JOINT SURGERY(BR) 2009; 91-B:1566-74, S. GLYN-JONES, H. PANDIT, Y.M. KWON, H. DOLL, H.S. GILL, D. W. MURRAY FROM NUFFIELD ORTHOPAEDIC CENTRE, UNIVERSITY OF OXFORD, OXFORD, ENGLAND, REPORTED 8 CONSERVE PLUS (C+) REVISIONS FOR "A CONFIRMED DIAGNOSIS OF PSEUDOTUMOUR."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE LEAD. R-WAVES AND THE PACING LEAD IMPEDANCE SHOWED A DECREASE SINCE IMPLANT AND THE CAPTURE THRESHOLD HAD INCREASED. THE SENSITIVITY WAS RESOLVED WITH PROGRAMMING. THE LEAD WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R