BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2089547 · Received March 31, 2011

    Report

    Report Number
    1644408-2011-00169
    Event Type
    Other
    Date Received
    March 31, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    N/A
    PMA / PMN Number
    K973685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT REPORTED PAIN. THE DOCTOR SUSPECTED AN INFECTION, X-RAY REVEALED THE STEM BROKE WHERE THE NECK MEETS THE TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN N/A ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention 499-38-000, LOT 53800097| 499-38-009, LOT 53784239