BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.

    MDR report key: 19086584 · Received April 11, 2024

    Report

    Report Number
    0002648920-2024-00101
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 11, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024124813
    PMA / PMN Number
    K002960
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: AUSTRALIA. D10: CAT#: 65620005821, LOT #: 63382517 SHELL POROUS WITHOUT HOLES 58 MM O.D. CAT#: 00811400410, LOT #: 63724908 FEMORAL STEM12/14 NECK TAPER. CAT#: 4000-8775-036-04, LOT #: 2890293 DELTA CERAMIC FEMHEAD + 7 36MM. CAT#: 00801102028, LOT #: 63862008 ALLEN MEDULLARY CEMENT PLUGS. CUSTOMER INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE REPORTED ISSUE CANNOT BE CONFIRMED. 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 · 0

    IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO DISLOCATION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447073 TRILOGY LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D. PROTHESIS HIP LPH ZIMMER MANUFACTURING B.V. N/A 63417809 00889024124813

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Hospitalization| R