BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP STEM

    MDR report key: 2912757 · Received January 7, 2013

    Report

    Report Number
    2249697-2013-90054
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    August 1, 2012
    Report Date
    December 17, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT BEGAN HAVING PAIN AND SWELLING IN THE LEFT HIP IN (B)(6) 2012. PATIENT HAS INTENSE PAIN WHEN SITTING FOR LONG PERIODS AND GOING UP STAIRS. THE HIP IS SORE TO THE TOUCH. PATIENT HAS HAD AN MRI AND BONE SCAN AND IS SCHEDULED FOR BLOOD TEST. PATIENT WILL HAVE A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8225 UNKNOWN LEFT HIP STEM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other