BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 3172501 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19014
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    December 12, 2012
    Report Date
    June 3, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    (B)(4). ADDED: AGE, CATALOG, LOT, AND UDI, 510K.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, LACK OF MOBILITY AND HIGH LEVELS OF METAL IONS.

    Description of Event or Problem · 1

    PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273400 PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US 1081156

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other