BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E

    MDR report key: 23476685 · Received November 5, 2025

    Report

    Report Number
    0001822565-2025-04001
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 9, 2025
    Report Date
    February 3, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572676
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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. COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 110024461 LOT# 404810 G7 DUAL MOBILITY LINER 38MM C. CAT# 650-1055 LOT# 3128049 CER BIOLOXD OPTION HD 28MM. CAT# 650-1064 LOT# 3123237 CER OPTION TYPE 1 TPR SLEVE -6. G2: FOREIGN ¿ JAPAN: THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO THE HEAD AND BEARING DISASSOCIATION, CONSISTENT WITH INTRAPROSTHETIC DISLOCATION. THE HEAD AND BEARINGS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606985 VIVACIT-E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 65509339 00889024572676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R