BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2190448 · Received July 29, 2011

    Report

    Report Number
    2249697-2011-01140
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF IT BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT PRESENTED WITH POSSIBLE COCR ALLERGY." THE HIP COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA MJD7JE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other