BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 1843096 · Received September 23, 2010

    Report

    Report Number
    1043534-2010-00392
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 14, 2009
    Report Date
    July 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO USER FACILITY HAS BEEN IDENTIFY TO DATE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00393, 00394, 00395.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. PACKAGE INSERT REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO LOOSENING OF ACETABULAR COMPONENT WITH HISTORY OF POOR INGROWTH.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO LOOSENING OF ACETABULAR COMPONENT WITH HISTORY OF POOR INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS CUP HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. 115286921

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R