BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY ACETABULAR LINER

    MDR report key: 8840658 · Received July 30, 2019

    Report

    Report Number
    0002648920-2019-00555
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    October 16, 2015
    Report Date
    July 30, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOLOX® OPTION, HEAD # ITEM 00877703201 LOT 2790029, TM MODULAR CUP 50MM CLUSTER # ITEM 00620205022 LOT 61483936, TRILOGY BONE SCREW 6.5X20 # ITEM 00625006520 LOT 61458804, FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 9 STANDARD OFFSET # ITEM 00771100900 LOT 61489733. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. THE PATIENT HAD TWISTED WHILE GETTING UP AND FELT A POP TO THE LEFT HIP. PATIENT SUFFERED FROM ACUTE PAIN, DIFFICULTY AMBULATING, AND INABILITY TO BEAR WEIGHT. RADIOGRAPHS DEMONSTRATED AN ANTERIOR SUPERIOR DISLOCATION OF LEFT HIP AND THE PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE. FOLLOWING REDUCTION, DESIRED STABILITY AND RANGE OF MOTION WAS ACHIEVED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED FROM LEFT HIP ANTERIOR SUPERIOR DISLOCATION REQUIRING CLOSED REDUCTION UNDER CONSCIOUS SEDATION IN THE EMERGENCY ROOM APPROXIMATELY ONE MONTH POST HIP REVISION SURGERY. SHE WAS THEN ADMITTED TO HOSPITAL FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635251 TRILOGY LONGEVITY ACETABULAR LINER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63023414

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R