BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALTRX +4 10D 40IDX58OD

    MDR report key: 1899016 · Received October 27, 2010

    Report

    Report Number
    1818910-2010-08167
    Event Type
    Other
    Date Received
    October 27, 2010
    Date of Event
    September 3, 2009
    Report Date
    October 14, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K062148
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PT WAS REVISED TO ADDRESS RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRX +4 10D 40IDX58OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA C52AE1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention