BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 54MM

    MDR report key: 2943916 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-11908
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 26, 2011
    Report Date
    January 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-03830. THIS REPORT, 1818910-2013-11908, WILL BE REJECTED,1818910-2013-03830 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    MAUDE REPORT ((B)(4)) VOLUNTARILY SUBMITTED BY A PATIENT STATES THAT S/HE WAS REVISED TO ADDRESS PAIN AND LEG LENGTH DISCREPANCY, WITH WEAKNESS IN THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47938 PINNACLE SECTOR II CUP 54MM ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. Y2HE11000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention