BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #3

    MDR report key: 2893434 · Received December 21, 2012

    Report

    Report Number
    9616680-2012-01460
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 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
    NY, US
    Reporter Occupation
    OTHER

    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 PT IS EXPERIENCING HIP PAIN. PRIMARY HIP PERFORMED USING DIRECT ANTERIOR APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 34114606

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R