BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAGE(R) CUP IMPACTOR W/TIP ALIGNMENT GUIDE

    MDR report key: 2406788 · Received January 10, 2012

    Report

    Report Number
    1043534-2012-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    October 25, 2011
    Report Date
    December 5, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED.

    Additional Manufacturer Narrative · 1

    DEVICE #2: THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE EVALUATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-00001. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY THE SURGEON COULD NOT REMOVE THE CUP FROM THE IMPACTOR. THIS CAUSED A 30 MIN. DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAGE(R) CUP IMPACTOR W/TIP ALIGNMENT GUIDE HIP INSTRUMENT HWA WRIGHT MEDICAL TECHNOLOGY, INC. 093100193

    Patients

    Seq Age Sex Outcome Treatment
    1