BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII, MODULAR STEM

    MDR report key: 2901584 · Received January 3, 2013

    Report

    Report Number
    9616680-2012-01538
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVAL. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN ABGII REMOVED FOR PAIN. THE SURGEON STATED THAT WHEN REMOVING IT, IT CAME OUT VERY EASILY AND THAT SOMETHING ELSE WAS GOING ON AND IT MAY HAVE TO DO WITH THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201 ABGII, MODULAR STEM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R