BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP STEM

    MDR report key: 2922555 · Received January 15, 2013

    Report

    Report Number
    2249697-2013-90133
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    June 24, 2011
    Report Date
    December 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
    CA, US
    Reporter Occupation
    OTHER

    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 ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO IS REC'D IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION 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 DEVICES IN BOTH HIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22687 UNKNOWN LEFT HIP STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other