BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10° CROSSFIRE INSERT 36 MM ID

    MDR report key: 4013383 · Received August 15, 2014

    Report

    Report Number
    0002249697-2014-03122
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K021911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION NOTED DAMAGE TO THE LINERS LOCKING MECHANISM. ALSO NOTED IS DAMAGE TO THE LIP WHERE THE GROOVES ARE LOCATED. THIS DAMAGE WAS THE RESULT OF MALALIGNMENT WITH THE SHELL. WHEN IMPACTED IN MALALIGNMENT THE LINER WILL NOT PROPERLY ASSEMBLE CAUSING DAMAGE AS NOTED. THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE EVENT TO BE ATTEMPTING TO ASSEMBLE MALALIGNED DEVICES. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DOCTOR IMPLANTED A 54MM TRITANIUM REVISION CUP AND SCREWS WITHOUT INCIDENT. AFTER IMPLANTING THE TRIDENT CROSSFIRE 10 DEGREE LINER HE REMARKED THAT IT FELT LOOSE AND DID NOT FIT CORRECTLY. HE TRIED IMPACTING AGAIN WITH NO CHANGE. WE CHECKED THE BOXES AND NOTED THAT THE LINER WAS THE CORRECT ALPHA CODE (E). HE ASKED IF I HAD ANOTHER, WHICH I DID, SO HE CAREFULLY REMOVED THE LINER AND IMPLANTED ANOTHER TRIDENT CROSSFIRE 10 DEGREE LINER. THE SECOND LINER FIT CORRECTLY.

    Description of Event or Problem · 1

    DOCTOR IMPLANTED A 54MM TRITANIUM REVISION CUP AND SCREWS WITHOUT INCIDENT. AFTER IMPLANTING THE TRIDENT CROSSFIRE 10 DEGREE LINER HE REMARKED THAT IT FELT LOOSE AND DID NOT FIT CORRECTLY. HE TRIED IMPACTING AGAIN WITH NO CHANGE. WE CHECKED THE BOXES AND NOTED THAT THE LINER WAS THE CORRECT ALPHA CODE (E). HE ASKED IF I HAD ANOTHER, WHICH I DID, SO HE CAREFULLY REMOVED THE LINER AND IMPLANTED ANOTHER TRIDENT CROSSFIRE 10 DEGREE LINER. THE SECOND LINER FIT CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490588 TRIDENT 10° CROSSFIRE INSERT 36 MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MNH5DM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other