BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACCOLADE STEM #3 127 DEGREE

    MDR report key: 2161661 · Received July 7, 2011

    Report

    Report Number
    9616680-2011-00454
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 THAT, "PATIENT'S STEM SUBSIDED SO HE WAS REVISED. THE SURGEON REFUSED TO RELEASE X-RAYS OR MEDICAL RECORDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ACCOLADE STEM #3 127 DEGREE IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention