BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONGEVITY CONST LINER 50X28

    MDR report key: 23061624 · Received September 16, 2025

    Report

    Report Number
    0001822565-2025-03419
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 21, 2025
    Report Date
    October 6, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    UDI-DI
    00889024668881
    PMA / PMN Number
    K071718
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2; G3; H2; H4; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, AN UNKNOWN COMPETITOR HEAD WAS USED WITH A ZIMMER BIOMET LINER. AS PER INSTRUCTIONS FOR USE, COMPATIBILITY STATES - DUE TO THE ACQUISITION OF PRE-EXISTING PRODUCT LINES, ZIMMER BIOMET OR ITS AFFILIATES HAS INITIATED A TESTING PROGRAM TO EVALUATE THE COMPATIBILITY OF THESE DEVICES WITH IMPLANTS AND COMPONENTS MADE OR DISTRIBUTED BY ALL ZIMMER BIOMET OR ITS AFFILIATES, WHICH INCLUDE ZIMMER GMBH (PREVIOUSLY CENTERPULSE ORTHOPEDICS LTD.), ZIMMER TRABECULAR METAL TECHNOLOGY, INC. (PREVIOUSLY IMPLEX CORP.), ZIMMER U.K. LTD., ZIMMER AUSTIN, INC. (PREVIOUSLY CENTERPULSE ORTHOPEDICS, INC.) AND BIOMET ORTHOPEDIC COMPANIES. ONLY AUTHORIZED COMBINATIONS SHOULD BE USED. IT IS UNKNOWN IF THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: AUSTRALIA. THE PRODUCT WAS REQUESTED BUT WAS NOT RETURNED BY THE HOSPITAL AND WILL THEREFORE NOT BE SENT TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1-YEAR POST IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, THE TRILOGY LINER AND COMPETITOR¿S HEAD WERE REPLACED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295236 LONGEVITY CONST LINER 50X28 PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. 66867591 00889024668881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R UNK SHELL.UNK STEM.UNK COMPETITOR HEAD.