BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 2071552 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06318
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K083642
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    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

    PT WAS REVISED TO ADDRESS HIP PAIN AND ELEVATED ION LEVELS. TISSUE WAS FOUND TO LOOK BROWN AND SANDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX50OD KWA DEPUY ORTHOPAEDICS, INC. NA 2760507

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention