BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR STEM

    MDR report key: 2871961 · Received December 6, 2012

    Report

    Report Number
    9616680-2012-01327
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICES WERE NOT AVAILABLE FOR EVAL BECAUSE THE PT RETAINED THEM. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABGII SHOWED ELEVATED IONS. SURGEON DECIDED TO REVISE STEM. UPON OPENING, BLACK SLUDGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII MODULAR STEM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G2991433

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R