BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY HIGLY CROSSLINKED LINER

    MDR report key: 5271993 · Received December 7, 2015

    Report

    Report Number
    1822565-2015-02574
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    December 13, 2011
    Report Date
    December 10, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED SINCE THE DEVICES STILL REMAIN IMPLANTED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE OPERATIVE NOTES CONFIRMS THAT THE PATIENT UNDERWENT LEFT TOTAL HIP REPLACEMENT DUE TO OSTEOARTHRITIS. IT WAS NOTED THAT THE TRIALS GAVE EXCELLENT STABILITY. THE TRIALS WERE REMOVED AND FINAL COMPONENTS WERE IMPLANTED WHICH ALSO GAVE EXCELLENT STABILITY. NO COMPLICATIONS WERE NOTED. REVIEW OF THE CONSULTATION NOTES STATES THAT THE PATIENT WAS OPENING A CAR DOOR AND WENT TO TURN AROUND AND FELT A POP IN HER LEG. THE PATIENT HAD IMMEDIATE PAIN AND INABILITY TO BEAR WEIGHT. INITIAL PHYSICAL EXAMINATION NOTED THAT THE PATIENT'S LEFT LOWER EXTREMITY WAS STUCK IN EXTERNAL ROTATION. IT WAS ALSO NOTED IN THE NOTES THAT THE RADIOGRAPHS SHOWED THAT THE PATIENT HAD A LEFT ANTERIOR HIP DISLOCATION AND THE PATIENT HAD NO OTHER NOTED FRACTURES OR CHANGE IN POSITIONING OF HIP COMPONENTS. IT WAS ALSO NOTED THAT THE PATIENT UNDERWENT CLOSED REDUCTION AND THE PATIENT WAS TO BE FEELING SIGNIFICANTLY BETTER AFTER THE PROCEDURE. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. REVIEW OF THE COMPATIBILITY OF THE DEVICES CONFIRMED THAT THESE ARE AN APPROVED COMPATIBLE COMBINATION. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THESE DEVICES ARE USED FOR TREATMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #00877503201, BIOLOX DELTA HEAD, LOT #2591037 - MANUFACTURED BY ZIMMER (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED A PATIENT'S HIP DISLOCATED AFTER TWISTING. A CLOSED REDUCTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800703 TRILOGY LONGEVITY HIGLY CROSSLINKED LINER LZO LZO ZIMMER INC 61780367

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other