BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL FEM COMP STD

    MDR report key: 2910451 · Received January 4, 2013

    Report

    Report Number
    9610726-2013-90004
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JDI
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 PT WAS REVISED FOR DISLOCATION. NO FURTHER IMPLANT OR INFO AVAILABLE DUE TO HOSP POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4131 PROXIMAL FEM COMP STD IMPLANT JDI STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R