BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR LIP LNR 32IDX60OD

    MDR report key: 1772268 · Received July 22, 2010

    Report

    Report Number
    1818910-2010-04790
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K001534
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 LOW GRADE INFECTION WITH A HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR LIP LNR 32IDX60OD LPH DEPUY ORTHOPAEDICS, INC. NA Z14C71000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention