BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR COMPLETE

    MDR report key: 25220176 · Received May 19, 2026

    Report

    Report Number
    0001822565-2026-01633
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024509177
    PMA / PMN Number
    K182048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00-8775-036-03 LOT# 3254007 BIOLOX DELTA HD 12/14 36X+3.5 CAT# 110010243 LOT# 67442615 G7 OSSEOTI 3 HOLE SHELL 50MM D G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY SIX WEEKS POST-IMPLANTATION DUE TO INFECTION. ALL FEMORAL AND ACETABULAR COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439125 AVENIR COMPLETE PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER BIOMET, INC. 3217529 00889024509177

    Patients

    Seq Age Sex Outcome Treatment
    1