BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7® VIVACIT-E®

    MDR report key: 25323217 · Received May 28, 2026

    Report

    Report Number
    0001822565-2026-01708
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024520493
    PMA / PMN Number
    K190660
    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# 31-323230 LOT# 67479832, CAT# 6250-65-25 LOT# J7683125, CAT# 110010245 LOT# 67606150, CAT# 11-300913 LOT# 480140, CAT# 11-301301 LOT# 66723665, CAT# 650-0660 LOT# 3233280. G2: FOREIGN ¿ EVENT OCCURRED IN AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO HOSPITAL POLICY; 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 WAS REVISED APPROXIMATELY 1-MONTH POST-IMPLANTATION DUE TO INFECTION. HEAD AND LINER WERE REVISED. THE PATIENT WAS INVOLVED REQUIRING REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576303 G7® VIVACIT-E® PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 67210393 00889024520493

    Patients

    Seq Age Sex Outcome Treatment
    1