BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19657704 · Received July 2, 2024

    Report

    Report Number
    0002648920-2024-00217
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    May 20, 2020
    Report Date
    July 2, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    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. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT TOTAL HIP ARTHROSCOPY WAS PERFORMED. APPROXIMATELY NINE YEARS AFTER POST IMPLANTATION, THE PATIENT WAS BENDING AND SUFFERED A DISLOCATION. A CLOSED REDUCTION WAS SUCCESSFUL IN THE OPERATING ROOM. THE PATIENT THEN EXPERIENCED A PULMONARY EMBOLISM THAT WAS RESOLVED. A SECOND DISLOCATION OCCURRED APPROXIMATELY THREE WEEKS LATER AND WAS ALSO CORRECTED WITH A CLOSED REDUCTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE DISLOCATION. NO DEVICE PROBLEM WAS FOUND FOR THE PULMONARY EMBOLISM. A REVIEW BY THE HEALTH CARE PROFESSIONAL DETERMINED IT WAS NOT DEVICE RELATED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0002648920-2024 -00061.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602960 TRILOGY LONGEVITY LINER 20 DEGREE ELEVATED RIM 28 MM I.D. PROTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 61312811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R