BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSERVE(R) PLUS HA CUP

    MDR report key: 2761306 · Received September 26, 2012

    Report

    Report Number
    1043534-2012-01237
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 13, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. AT THIS TIME, NO REVISION DATE HAS BEEN REPORTED, NOR HAS ANY PRODUCT ISSUE BEEN REPORTED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01238, 01239, 01240. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. 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.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT NEEDS A TOTAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS HA CUP HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 087438258

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention