BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODC LINER

    MDR report key: 22968165 · Received September 4, 2025

    Report

    Report Number
    MW5175661
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 2, 2025
    Manufacturer
    ZIMMER, INC. /ZIMMER BIOMET
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SURGEON WANTED TO REDUCE PATIENT'S OFFSET BY CHANGING THE ODC LINER. THE +1.15 HEAD WAS EXPLANTED AND A NEW ONE WAS PLACED. THERE WAS NO PATIENT CONSEQUENCE. NO DELAY WAS REPORTED. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495861 ODC LINER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER, INC. /ZIMMER BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown