BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE HIP STEM

    MDR report key: 2910431 · Received January 8, 2013

    Report

    Report Number
    2249697-2013-90064
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH AN ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT: "PATIENT HAS INJURIES SUSTAINED AS A RESULT OF THE IMPLANTATION OF A STRYKER REJUVENATE HIP REPLACEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10239 UNKNOWN REJUVENATE HIP STEM IMPLANT MEH STRYKER ORHTOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other