BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. MODULAR STEM

    MDR report key: 2821518 · Received October 24, 2012

    Report

    Report Number
    2249697-2012-02034
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    November 22, 2019
    Report Date
    February 21, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    Z-2089/2090-2012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 WAS REPORTED THAT PATIENT IS CURRENTLY SUFFERING NO PAIN. PATIENT STATES THAT SHE HAS HAD AN MRI, AN X-RAY, AND BLOOD WORK DONE TO TEST FOR CHROMIUM AND COBALT IN (B)(6) 2012. THE PATIENT IS REPORTING THAT THE X-RAY IS SHOWING FLUID BUILD UP. PATIENT IS ALSO REPORTING THAT DOCTOR IS RECOMMENDING THAT SHE BE EVALUATED IN SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII. MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH STRYKER ORTHOPAEDICS-MAHWAH NA G2885257

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R