BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE C CS 127 NECK 35 MM SIZE 4 STEM W/ DISTA

    MDR report key: 2202413 · Received August 4, 2011

    Report

    Report Number
    2249697-2011-01164
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    May 9, 2008
    Report Date
    July 13, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K022555
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 THROUGH THE ATTORNEY FOR THE PATIENT THAT, "HIP STEM WAS REVISED AS IT WAS GROSSLY LOOSENED AND COULD PISTON IN AND OUT OF THE SHAFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE C CS 127 NECK 35 MM SIZE 4 STEM W/ DISTA IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA 12761101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R