BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 3463816 · Received November 12, 2013

    Report

    Report Number
    1043534-2013-01875
    Event Type
    Injury
    Date Received
    November 12, 2013
    Date of Event
    June 11, 2010
    Report Date
    October 18, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6). THIS IS THE SAME EVENT AS 1043534-2013-01876.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED (B)(6) 2017. ALLEGEDLY THE PATIENT WAS REVISED DUE TO OTHER INDICATIONS FOR REVISION (RIGHT). UPDATED EXPLANT DATE, REVISION NJR NUMBER, INSTITUTION AND CONTACT NAME. REVISION NJR NUMBER: (B)(4). BMI: 33. PRIMARY ASA: P2- MILD DISEASE NOT INCAPACITATING.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO ASEPTIC LOOSENING SOCKET; LYSIS SOCKET; MALALIGNMENT SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582099 CONSERVE(R) PLUS CUP HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 107455549

    Patients

    Seq Age Sex Outcome Treatment
    1 49.5 YR Required Intervention