BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIOMET FEMORAL HEAD

    MDR report key: 23802442 · Received December 15, 2025

    Report

    Report Number
    0001822565-2025-04497
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 18, 2025
    Report Date
    May 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024498785
    PMA / PMN Number
    K183457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110031009 VIVACIT-E DM BEARING 28X38MM 67075135. G2: FOREIGN: JAPAN. SUGGESTED COMPONENT CODE: MECHANICAL (G04) - HEAD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INITIAL SURGERY WAS PERFORMED USING A G7 DUAL MOBILITY (DM) SYSTEM. A REOPERATION WAS LATER PERFORMED DUE TO AN INTRAPROSTHETIC DISLOCATION (IPD). ON THIS OCCASION, FURTHER DISLOCATION OCCURRED. A REVISION PROCEDURE WAS COMPLETED TO REPLACE THE BEARING AND FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105661 ZIMMER BIOMET FEMORAL HEAD PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 67096229 00889024498785

    Patients

    Seq Age Sex Outcome Treatment
    1