BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 28X42MM

    MDR report key: 2922093 · Received January 11, 2013

    Report

    Report Number
    2249697-2013-90123
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 23, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K800207
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRIDENT CONSTRAINED LINER BECAME DISSOCIATED WHILE AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18074 UHR BIPOLAR 28X42MM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA MLH5K9

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other