BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R120 HIP

    MDR report key: 3840489 · Received May 30, 2014

    Report

    Report Number
    1644408-2014-00319
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    PMA / PMN Number
    K011774
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DJO SURGICAL RECEIVED THIS COMPLAINT OF A REPORTABLE EVENT, AND HAS DETERMINED THAT THE MANUFACTURER OF THE DEVICE IN QUESTION WAS (B)(4). AS PART OF ENCORE MEDICAL'S ACQUISITION OF THE (B)(4) PRODUCT LINES, (B)(4) AGREED TO ASSUME ALL REGULATORY RESPONSIBILITIES FOR PRODUCT IMPLANTED PRIOR TO ENCORE'S ACQUISITION OF THEIR PRODUCT LINES ON (B)(4) 2005.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO A LOOSE FEMORAL STEM THE SURGEON PERFORMED A POLY SWAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319423 R120 HIP MODULAR CEMENTED STEM JDI ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other| R