BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF INS SZ 3 10MM

    MDR report key: 1772293 · Received July 22, 2010

    Report

    Report Number
    1818910-2010-05043
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S087
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PRESENTED WITH PAIN IN RIGHT KNEE & X-RAYS REVEALED POLY INSERT HAD SPUN OUT AND JAMMED BETWEEN THE FEMUR AND TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG RPF INS SZ 3 10MM NJL DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA D21CA4000

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention