BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMA HIP

    MDR report key: 2631633 · Received June 21, 2012

    Report

    Report Number
    1644408-2012-00321
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DJO SURGICAL RECEIVED THIS COMPLAINT OF A REPORTABLE EVENT AND HAS DETERMINED THAT THE MANUFACTURE OF THE DEVICE WAS OSTEOIMPLANT TECHNOLOGIES, INC. (OTI), NOW KNOWN AS PINNACLE HOLDING, INC. AS PART OF ENCORE MEDICAL'S ACQUISITION OF THE OTI PRODUCT LINES, OTI AGREED TO ASSUME ALL REGULATORY RESPONSIBILITIES FOR PRODUCT IMPLANTED PRIOR TO ENCORE'S ACQUISITION IF THEIR PRODUCT LINES ON FEBRUARY 22, 2005. THIS INFORMATION WILL BE FORWARDED TO (B)(6).

    Description of Event or Problem · 1

    REVISION SURGERY/INSTRUMENT FAILURE - THE H50 NECK TRIAL STRIPPED DURING SURGERY. THE INSTRUMENT FAILURE LED TO A 45 MINUTE DELAY IN SURGERY, AS WELL AS THE NEED TO USE OTHER INSTRUMENTATION TO CUT INTO THE SCREW TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMA HIP 50MM LATERAL NECK INSTRUMENT LXH ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention