BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING 28X44MM

    MDR report key: 25044875 · Received April 30, 2026

    Report

    Report Number
    0001822565-2026-01425
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572706
    PMA / PMN Number
    K190656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT#: 00877502803, LOT# 3220540 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 28/+3.5, TAPER 12/14. G2: FOREIGN - EVENT OCCURRED IN ITALY. 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 AN INITIAL HIP PROCEDURE. THE PATIENT WAS REVISED APPROXIMATELY 1 MONTH LATER DUE TO DISASSOCIATION OF THE HEAD AND BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53867 VIVACIT-E DM BEARING 28X44MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER BIOMET, INC. 66941424 00889024572706

    Patients

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