BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR LONG NECK

    MDR report key: 2926236 · Received January 16, 2013

    Report

    Report Number
    9616680-2013-90144
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    February 24, 2011
    Report Date
    January 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K092400
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOTICE WAS RECEIVED FROM (B)(6) ALLEGING THAT PATIENT HAD SUSTAINED PERSONAL INJURIES ON (B)(6) 2011 FROM THE IMPLANTATION OF THE STRYKER REJUVENATE HIP COMPONENTS. ADDITIONAL INFORMATION REPORTED VIA SALES REP: COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION. SERUM CHROME 1.0 PPB, COBALT 3.8 PPB, JOINT FLUID ASPIRATE LEVELS COBALT 220 MCG MCG/L, CHROME 48 MCG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23709 ABGII MODULAR LONG NECK IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA G2973114

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention