BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 50MM

    MDR report key: 1902088 · Received November 10, 2010

    Report

    Report Number
    1818910-2010-08650
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 11, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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

    REVISE THE DEVICE AS FOR A MOBILIZATION OF THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SECTOR II CUP 50MM 87 KWA, LZO KWA DEPUY ORTHOPAEDICS, INC. NA CT7GC1000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention