BEUDAMED
    FDA Adverse Event Other Summary report: N

    OTI HIP

    MDR report key: 3432909 · Received October 17, 2013

    Report

    Report Number
    1644408-2013-00576
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    October 1, 2013
    Report Date
    September 17, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - THE PT HAD AN OSTEOIMPLANT TECHNOLOGIES INC. HIP STEM. DUE TO THE PT HAVING SEIZURES AND DISLOCATING. THE SURGEON REMOVED THE EXACTEK LINER AND REPLACED IT WITH A CONSTRAINED LINER. HE ALSO REPLACED THE FEMORAL HEAD. REFERENCE FIRST REVISION, DATE OF SURGERY (B)(6) 2012, PC-2012-00916.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533197 OTI HIP FEMORAL HEAD, 28MM, +5MM JDI ENCORE MEDICAL, L.P. 233G1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention