BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 50MM

    MDR report key: 2033816 · Received March 17, 2011

    Report

    Report Number
    1818910-2011-04337
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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

    PT REVISED FOR DISLOCATION DUE TO ACETABULAR CUP PLACEMENT. LINER REPLACED WITH CONSTRAINED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SECTOR II CUP 50MM 87KWA, LZO KWA DEPUY ORTHOPAEDICS, INC. NA C78F61000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention