BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 50MM

    MDR report key: 3073124 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15779
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK093646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2012-83011. THIS REPORT, 1818910-2013-15779, WILL BE REJECTED. 1818910-2012-83011 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 MALPOSITIONING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175372 PINN SECTOR W/GRIPTION 50MM ACETABULAR CUP LPH 1818910 DEPUY ORTHOPAEDICS, INC. 224085

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention