BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 2922525 · Received January 15, 2013

    Report

    Report Number
    2249697-2013-90135
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    October 31, 2011
    Report Date
    December 26, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE REASON FOR THE STERILIZATION 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 THROUGH THE FILING OF A LAWSUIT THAT: ALLEGEDLY, AFTER IMPLANTATION OF THE DEVICE, THE PT BEGAN EXPERIENCING SIGNIFICANT PAIN AND DISCOMFORT. IT IS ALLEGED THAT THE PT WILL REQUIRE REVISION SURGERY TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22208 UNKNOWN STEM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other