BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR LONG NECK

    MDR report key: 2831128 · Received November 2, 2012

    Report

    Report Number
    9616680-2012-00990
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    April 19, 2011
    Report Date
    October 18, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD¿L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NO EVENT AT TIME OF SURGERY HOWEVER NOW PATIENT HAS ELEVATED ION LEVELS AND THE MRI SHOWS SIGNS OF METALLOSIS AROUND PROXIMAL FEMUR. METALLOSIS FROM MODULAR NECK AND STEM METAL DEBRIS- UNRESOLVED. REVISION SURGERY BOOKED FOR THE (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII MODULAR LONG NECK IMPLANT MEH STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI NA G2684178

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R