BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C.* FLUT TIB ROD 75X22MM

    MDR report key: 3161548 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18581
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    REASON FOR REVISION: THE REVISION MODULAR FEMORAL COMPONENT HAS MOVED INTO VARUS AND THE FLUTED STEM IS CAUSING THIGH PAIN AND DEFORMITY WITH A RESULTANT REDUCTION IN FUNCTION FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263237 P.F.C.* FLUT TIB ROD 75X22MM TIBIAL FLUTED ROD JWH DEPUY ORTHOPAEDICS 260922RA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention