BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMBA HIP SLIDE

    MDR report key: 5440729 · Received February 17, 2016

    Report

    Report Number
    5440729
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 21, 2016
    Report Date
    February 10, 2016
    Manufacturer
    INNOMED CORP.
    Product Code
    NBH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY FOLLOWING A RIGHT TOTAL HIP ARTHROPLASTY, POST OPERATIVE RADIOGRAPHS VIEWED BY THE SURGED NOTED TO BE ABNORMAL, PATIENT RETURNED BACK TO SURGERY. THE SURGEON EXPLORED THE SIGHT FINDING A FOREIGN OBJECT WITHIN THE HIP, THE FOREIGN OBJECT WAS A CORNER OF THE NAMBA HIP SLIDE THAT HAD BROKEN OFF. APPROXIMATE LENGTH 3.5 CM, APPROXIMATE DEPTH 1.0 CM. DID REQUIRE REPLACEMENT OF NEW HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98339 NAMBA HIP SLIDE ACCESSORIES,ARTHROSCOPIC NBH INNOMED CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other