BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 56MM

    MDR report key: 1884784 · Received October 22, 2010

    Report

    Report Number
    1818910-2010-07855
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    February 22, 2008
    Report Date
    October 13, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    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

    LITIGATION PAPERS ALLEGED, THE PATIENT WAS REVISED TO ADDRESS FAILURE OF THE LOCKING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SECTOR II CUP 56MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA B3DB91

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention