BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 50MM

    MDR report key: 1053518 · Received May 27, 2008

    Report

    Report Number
    1818910-2008-02158
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 14, 2008
    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
    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

    FRACTURED ACETABULUM DURING PRIMARY SURGERY. HAD TO REAM UP AND IMPLANT LARGER CUP WITH SCREWS. THIS PROBLEM RESULTED IN A 1-HOUR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 300 ACET CUP 50MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA B3DA81000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention