BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - OMNIFIT HRX 127 DEG HIP STEM#10

    MDR report key: 1894558 · Received November 5, 2010

    Report

    Report Number
    2249697-2010-01477
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 14, 2009
    Report Date
    October 13, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    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'S SON CALLED TO REPORT THAT HIS MOM IS EXPERIENCING PAIN. HAS TROUBLE STANDING ON IT. (B)(6) WAS WONDERING IF HER IMPLANT WAS PART OF ANY TYPE OF RECALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - OMNIFIT HRX 127 DEG HIP STEM#10 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other| R