BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP STEM

    MDR report key: 2926225 · Received January 16, 2013

    Report

    Report Number
    2249697-2013-90154
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 1, 2010
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS PAIN AT NIGHT WHILE SLEEPING. PATIENT HAS INTERMITTENT PAIN ON A DAILY BASIS. PATIENT HAS HAD BLOOD WORK AND AN MRI. HER SURGEON SAYS THE RESULTS ARE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23555 UNKNOWN RIGHT HIP STEM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other