BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY LINER 20 DEGREE ELEVATED RIM 28 MM I.D.

    MDR report key: 18879560 · Received March 11, 2024

    Report

    Report Number
    0001822565-2024-00845
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    May 20, 2020
    Report Date
    July 2, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: CANADA. D10: CAT#: 6200-52-22, LOT#: 61237861 SHELL POROUS WITH CLUSTER HOLES 52 MM O.D. CAT#: 7711-11, LOT#: 61487763 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT. CAT#: 8018-28-02, LOT#: 61558147 FEMORAL HEAD. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2024-00060, 0001822565-2024-00846, 0002648920-2024 -00061.

    Additional Manufacturer Narrative · 0

    H11: UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 9 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS BENDING DOWN AND HAD A SUDDEN POSTERIOR RIGHT HIP DISLOCATION. A REDUCTION WAS ATTEMPTED IN THE EMERGENCY DEPARTMENT; HOWEVER, THE REDUCTION WAS UNSUCCESSFUL, AND THE PATIENT HAD TO HAVE A CLOSED REDUCTION IN THE OPERATING ROOM. AFTER THE CLOSED REDUCTION, THE PATIENT REPORTED CHEST PAIN THAT WAS WORSE WITH DEEP BREATHING. IT WAS DETERMINED THAT THE PATIENT HAD BILATERAL PULMONARY EMBOLISM. THE PATIENT WAS PLACED ON SUPPLEMENTAL OXYGEN AND ANTICOAGULATION THERAPY. THREE WEEKS LATER THE PATIENT WAS SITTING APPLYING LOTION AND DISLOCATED HER HIP FOR A SECOND TIME. THE PATIENT WAS REDUCED IN THE EMERGENCY DEPARTMENT. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010721 TRILOGY LONGEVITY LINER 20 DEGREE ELEVATED RIM 28 MM I.D. PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 61312811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H