BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT MODULAR STEM

    MDR report key: 2885184 · Received December 17, 2012

    Report

    Report Number
    2249697-2012-02704
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 1, 2010
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED A RECALL NOTIFICATION LETTER FROM HIS SURGEON. THE PT HAS BEEN EXPERIENCING SHARP MOVING PAINS AND SWELLING ON THE LEFT SIDE ON THREE OCCASIONS IN THE PAST THREE WEEKS. THE PAIN BEGINS AT THE HIP AND GOES DOWN THE OUTSIDE OF HIS LEG AND DOWN INTO THE KNEE. THE PAIN LASTS FOR A FEW DAYS AND CHANGES IN INTENSITY. THE PT IS SCHEDULED TO SEE HIS SURGEON ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LEFT MODULAR STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other