BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE HIP STEM

    MDR report key: 2915560 · Received January 10, 2013

    Report

    Report Number
    2249697-2013-90099
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 1, 2010
    Report Date
    December 20, 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
    NJ, 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 INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION 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 SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED "THROUGH THE FILING OF A LAWSUIT THAT THE PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN, SWELLING AND DISCOMFORT IN THE AREA OF THE DEVICE. IT IS ALLEGED THAT FURTHER DIAGNOSTIC WORKUP REVEALED ONE OR MORE OF THE FOLLOWING FINDINGS: THE PRESENCE OF PSEUDOTUMOR FORMATION, THE EXISTENCE OF A SIGNIFICANT FLUID COLLECTION ABOUT THE HIP PROSTHESIS, AND/OR BLOOD TESTING INDICATING THE PRESENCE OF HEAVY METAL ION CONTAMINATION. IT IS FURTHER ALLEGED THAT BASED UPON THESE FINDINGS AND IN LIGHT OF WORSENING SYMPTOMS, THE PATIENT WILL REQUIRE REVISION SURGERY IN THE FUTURE FOR REMOVAL OF THE REJUVENATE HIP IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14282 UNKNOWN REJUVENATE HIP STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other