BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1043534-2012-01166

    MDR report key: 2755932 · Received September 24, 2012

    Report

    Report Number
    1043534-2012-01166
    Event Type
    Injury
    Date Received
    September 24, 2012
    Date of Event
    October 14, 2010
    Report Date
    September 19, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K070785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER FDA, REOPENED FILE AS A USER ERROR IN ORDER TO REPORT AS PART OF A RETROSPECTIVE REVIEW OF CERAMIC HEADS. THIS IS THE SAME EVENT AS 1043534-2012-01167, 01168, 01169, 01170, 01171.

    Additional Manufacturer Narrative · 1

    CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. OTHER: MISAPPLICATION/MISUSE OF DEVICE.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT DISLOCATED TWICE. POOR CUP ALIGNMENT SUSPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention