BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #3

    MDR report key: 2850825 · Received November 21, 2012

    Report

    Report Number
    9616680-2012-01162
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMORAL HEAD DISASSOCIATED FROM THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE PLUS TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 9272003

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R