BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1043534-2012-01172

    MDR report key: 2756011 · Received September 24, 2012

    Report

    Report Number
    1043534-2012-01172
    Event Type
    Injury
    Date Received
    September 24, 2012
    Date of Event
    October 26, 2010
    Report Date
    September 19, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXA
    PMA / PMN Number
    P030027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER FDA, REOPENED FILE AS A REPORTABLE MALFUNCTION IN ORDER TO REPORT AS PART OF A RETROSPECTIVE REVIEW OF CERAMIC HEADS. THIS IS THE SAME EVENT AS 1043534-2012-01173.

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CAUSE OF EVENT UNKNOWN.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO A SOFT TISSUE RELATED ISSUE. ABDUCTOR TENDON REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HXA WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention