BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY LINER STANDARD 32 MM I.D.

    MDR report key: 20863213 · Received December 6, 2024

    Report

    Report Number
    0001822565-2024-03841
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    October 31, 2024
    Report Date
    January 29, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024123755
    PMA / PMN Number
    K990135
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT#00877503203 LOT# 2990793 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 32/+3.5, TAPER 12/14. CAT# 00620205022 LOT# 64309077 SHELL POROUS WITH CLUSTER HOLES 50 MM. CAT# 00786401220 LOT# 64150702 FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY EXTENDED NECK OFFSET SIZE 12 128 MM STEM LENGTH CEMENTLESS. CAT# 00625006540 LOT# 64424728 BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PAIN, DISLOCATION, AND SCAR TISSUE. 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 THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 5 YEARS LATER DUE TO RECURRENT DISLOCATIONS. DURING THE REVISION, THE HEAD WAS DISLOCATED. THE HEAD AND LINER WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516614 TRILOGY LONGEVITY LINER STANDARD 32 MM I.D. PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64118548 00889024123755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE.