BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1043534-2012-01165

    MDR report key: 2755963 · Received September 24, 2012

    Report

    Report Number
    1043534-2012-01165
    Event Type
    Injury
    Date Received
    September 24, 2012
    Date of Event
    August 11, 2010
    Report Date
    September 19, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 1043534-2012-01162, 01163, 01164.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT. THE ORIGINAL CUP WHICH HAD BEEN IMPLANTED BY A DIFFERENT SURGEON, APPEARED TO HAVE BEEN IMPLANTED IN A RETROVERTED POSITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention