BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 2870951 · Received December 12, 2012

    Report

    Report Number
    1043534-2012-01649
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 15, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED. THE PRODUCT WAS DIMENSIONALLY INSPECTED AND PHOTOGRAPHIC IMAGES WERE MADE OF THE PRODUCT. MEETS SPECIFICATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01650, 01651.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED CUP FOR POSSIBLE MOM. WHEN SURGEON PULLED CUP AND NECK, THERE WERE NO SIGNS OF MOM. CUP DID NOT HAVE A LOT OF INGROWTH ALSO THE NECK WAS EASY TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS CUP HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 017395628

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention