BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 1930759 · Received December 16, 2010

    Report

    Report Number
    1043534-2010-00519
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    September 16, 2009
    Report Date
    November 18, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00520, 00521, 00522. THIS EVENT OCCURRED IN (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT HISTORY REVIEWED AND ANALYSIS SHOWS NO TRENDS FOR THE ITEM OR LOT NUMBER. DEVICE HISTORY RECORD REVIEWED AND INDICATES THE PRODUCT MET SPECIFICATIONS WHEN MANUFACTURED. PACKAGE INSERT REVIEWED AND ADDRESSES THE ADVERSE EVENT ALLEGED. PRODUCT NOT RETURNED. WITH THE INFORMATION PROVIDED, ADDITIONAL INVESTIGATION IS NOT POSSIBLE; HOWEVER, NO PRODUCT-RELATED ISSUES COULD BE ISOLATED REGARDING THE EVENT.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT FELT PAIN AND UNCOMFORTABLENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS CUP HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. 019745511

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R