BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED EVOLUTION PIN PACK, 3 LONG, 2 COLLARED MATERIAL

    MDR report key: 3161616 · Received June 5, 2013

    Report

    Report Number
    MW5030474
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 13, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PORTION OF PIN BROKE DURING TOTAL KNEE ARTHROPLASTY. RETAINED IN PT SECURE IN BONE. SURGEON UNABLE TO REMOVE FROM BONE, SAID WOULD NOT HARM PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247909 ADVANCED EVOLUTION PIN PACK, 3 LONG, 2 COLLARED MATERIAL LXH WRIGHT MEDICAL TECHNOLOGY, INC 1492873

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR