BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING 28X38MM

    MDR report key: 22177904 · Received June 10, 2025

    Report

    Report Number
    0001822565-2025-01788
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 27, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572575
    PMA / PMN Number
    K190656
    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: 00-8775-028-02 12/14 CERAMIC FEM HEAD 0X28 3101746. G2: FOREIGN: JAPAN. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: D4, G3, G6, H2, H3, H4, H6, H11. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED DAMAGE TO THE RIM OF THE EXPLANTED BEARING. IT IS UNKNOWN IF IT WAS CAUSED BY THE DISASSOCIATION OR EXPLANT DAMAGE. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO IMPLANT DISASSEMBLE BETWEEN THE HEAD AND BEARING.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633586 VIVACIT-E DM BEARING 28X38MM PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 64844431 00889024572575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H