BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSEAL(R) IMPACTOR HOLE PLUG

    MDR report key: 2942548 · Received February 4, 2013

    Report

    Report Number
    1043534-2013-00203
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    September 17, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER ADDITIONAL INFORMATION RECEIVED, THIS COMPONENT WAS ALSO REMOVED DURING THE REVISION SURGERY PREVIOUSLY REPORTED. THIS IS THE SAME EVENT AS 1043534-2012-01402, 1043534-2013-00201, 00202.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT COMPLAINED OF PAIN. REVISION SURGERY PERFORMED ON LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46166 INTERSEAL(R) IMPACTOR HOLE PLUG HIP COMPONENT, CODE:LPH LPH WRIGHT MEDICAL TECHNOLOGY, INC. 115A031753

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention