BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE NECK

    MDR report key: 2922119 · Received January 11, 2013

    Report

    Report Number
    9616680-2013-90084
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    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

    THIS EVENT WAS REPORT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH AN ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT: "PT 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
    16376 UNKNOWN REJUVENATE NECK IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other