BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 3050804 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-15179
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    April 4, 2013
    Report Date
    June 25, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-15286. THIS REPORT, 1818910-2013-15179, WILL BE REJECTED; 1818910-2013-15286 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    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

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153227 PINNACLE MTL INS NEUT36IDX52OD ACETABULAR LINER KWA 8010379 DEPUY INTL., LTD. 2715662

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention