BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 2922547 · Received January 15, 2013

    Report

    Report Number
    2249697-2013-90136
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 20, 2010
    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
    AL, 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 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, SWELLING, AND DISCOMFORT IN THE AREA OF THE DEVICE. IT IS ALLEGED THAT THE PT'S SYMPTOMS AND PHYSICAL LIMITATIONS ARE CONSISTENT WITH, BUT NOT LIMITED TO, PSEUDO TUMOR FORMATION, THE EXISTENCE OF A SIGNIFICANT FLUID COLLECTION ABOUT THE HIP PROSTHESIS, AND/OR BLOOD TESTING INDICATING THE PRESENCE OF HEAVY METAL CONTAMINATION. IT IS FURTHER ALLEGED THAT THE PT HAS UNDERGONE REVISION SURGERY FOR REMOVAL OF THE REJUVENATE HIP IMPLANT, WHICH WAS PERFORMED ON (B)(6), 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22529 UNKNOWN STEM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention