BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT PLUS CEMENTED HIP STEMOBSOLETE

    MDR report key: 2010696 · Received February 25, 2011

    Report

    Report Number
    2249697-2011-00223
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K933561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REVISION HIP SURGEON DIAGNOSIS ASEPTIC LOOSENING. CEMENT OSTEONICS EON STEM SIZE 7 REMOVED AND SIZE 7 CEMENTED NORMALISED STEM INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT PLUS CEMENTED HIP STEMOBSOLETE IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA 45837501

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R