BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFLEX STEM

    MDR report key: 1900048 · Received November 9, 2010

    Report

    Report Number
    2249697-2010-01502
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT COMPLAINED OF LEG LENGTH DISCREPANCY AND ROTATION ISSUES. PLAN TO REVISE FEMUR, KEEP CUP MOD RESTORATION USED FOR FEMUR REPLACEMENT SERIES II LINER/CONSTRAINED USED. NO FURTHER INFO TO BE RELEASED PER HOSPITAL CONFIDENTIALITY POLICY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFLEX STEM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R