BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT STEM

    MDR report key: 2893435 · Received December 21, 2012

    Report

    Report Number
    2249697-2012-02769
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    June 14, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 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 PT WAS NOTIFIED OF THE RECALL BY THEIR SURGEON. THE PT REPORTS THAT THE IMPLANT SITE IS VERY SORE AND TENDER. THE PT OCCASIONALLY HAS PAIN IN THE LEG THAT CAUSES HER TO LIMP. THE PT HAS A FOLLOW-UP APPOINTMENT SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGHT STEM IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other