BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT CUP TIP

    MDR report key: 2823870 · Received October 10, 2012

    Report

    Report Number
    2249697-2012-01791
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, IMPACTOR TIP WILL NOT DETACH FROM CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT CUP TIP INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 813706

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other