BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 1111756 · Received August 12, 2008

    Report

    Report Number
    1818910-2008-03181
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LPH
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM. PATIENT ALSO COMPLAINED OF PAIN. THE ACETABULAR COMPONENT WAS REMOVED TO ADJUST THE ANTEVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SECTOR II CUP 52MM 87LPH LPH DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention