BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 32IDX54OD

    MDR report key: 3213188 · Received July 9, 2013

    Report

    Report Number
    1818910-2013-20735
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION.

    Description of Event or Problem · 1

    UPDATED PATIENT'S INITIALS, LAWYER AND LAW FIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313460 ALTRX NEUT 32IDX54OD TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDIC INC, 1818910 D75BG1000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other