BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS HUMERAL STEM 7X 75MM

    MDR report key: 2801473 · Received October 12, 2012

    Report

    Report Number
    9610726-2012-00322
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSD
    PMA / PMN Number
    K954559
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, SURGEON INDICATED CEMENT IS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRS HUMERAL STEM 7X 75MM IMPLANT HSD STRYKER ORTHOPAEDICS LIMERICK NA TEC255

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention