BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. MODULAR STEM

    MDR report key: 2120409 · Received June 2, 2011

    Report

    Report Number
    9616680-2011-00359
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    February 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K092400
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "REVISION PERFORMED BECAUSE OF PAIN - REVISION PERFORMED ON (B)(6), 2011 - PRIMARY THA - (B)(6), 2008."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII. MODULAR STEM IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA G2012906

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention