BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY LINER STANDARD 32 MM I.D.

    MDR report key: 21332856 · Received February 7, 2025

    Report

    Report Number
    0001822565-2025-00290
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    December 22, 2024
    Report Date
    March 26, 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 # 00-8775-032-02 LOT# 3182100 BIOLOX DELTA HEAD 12/14 32X0. CAT#00-7848-023-00 LOT# 66528181 KINECTIV MODULAR NECK G. CAT# 00620205222 LOT# 66624520 SHELL POROUS WITH CLUSTER HOLES 52 MM. CAT# 00625006520 LOT# 66814859 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH. CAT# 00625006520 LOT# 66791366 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH. CAT# 00771300700 LOT# 66483312 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 7.5. 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. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: G3; H2; H3; H6. 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: MULTIPLE INSTABILITY EPISODES WITH DISLOCATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED BASED ON THE MEDICAL RECORD FINDINGS. 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 2 MONTHS LATER DUE TO INSTABILITY AND DISLOCATION. DURING THE REVISION, THE SURGEON NOTED THAT THE POSTERIOR CAPSULE WAS ALREADY TRAUMATICALLY REMOVED, AND THE HIP WAS DISLOCATING IN THE SLEEPING POSITION. THE ACETABULAR COMPONENT WAS WELL-FIXED AND IN APPROPRIATE POSITION. THE FEMORAL COMPONENT WAS FOUND LACKING ANTEVERSION BUT WAS WELL-FIXED. THE HEAD AND LINER WERE REPLACED WITHOUT COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    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
    1247333 TRILOGY LONGEVITY LINER STANDARD 32 MM I.D. PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 66070576 00889024123755

    Patients

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