BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE HIP NECK

    MDR report key: 2911053 · Received January 4, 2013

    Report

    Report Number
    9616680-2013-90025
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    January 30, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 ADD¿L INFO IS AVAILABLE AT THIS TIME. IF ADD¿L INFO IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿PATIENT HAS PERSONAL INJURIES SUSTAINED ON (B)(6) 2012 AS THE RESULT OF THE RECALLED STRYKER REJUVENATE MODULAR STEM¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5180 UNKNOWN REJUVENATE HIP NECK IMPLANT MEH STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other