BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10" X3 INSERT 32MM ID

    MDR report key: 2090553 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00521
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 THAT, "DOCTOR STATED 'THE INSERT WILL NOT LOCK INTO THE CUP.'"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10" X3 INSERT 32MM ID IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MJJ1ME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention