BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFIX

    MDR report key: 2356349 · Received December 2, 2011

    Report

    Report Number
    1020279-2011-00500
    Event Type
    Injury
    Date Received
    December 2, 2011
    Date of Event
    November 28, 2011
    Report Date
    November 28, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO PAIN. THE OPERATING SURGEON OF THIS REVISION SAID THAT THE CAUSE OF THIS PAIN WAS TECHNICAL ERROR OF PRIMARY SURGERY BECAUSE FEMORAL COMPONENT'S SIZE AND POSITION WAS NOT APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFIX PROFIX POR FEMORAL LT SZ6 JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)| (B)(4)