BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT CEMENTED STEM

    MDR report key: 1953423 · Received December 28, 2010

    Report

    Report Number
    2249697-2010-01897
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, THEN, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD PAIN X-RAYS-SHOWED BROKEN CEMENT MANTLE-SURGEON REMOVED-STEM/HEAD/LINER AND CEMENT -REPLACED LINER-IMPLANTED A 195X18MM CONICAL STEM AND A 21 +10 CONE BODY WITH A 32MM HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT CEMENTED STEM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R