BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E

    MDR report key: 22236113 · Received June 17, 2025

    Report

    Report Number
    0001822565-2025-01976
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 16, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572812
    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: UNK COMPETITOR HEAD; CAT: 110010260 LOT: 7201865 G7 OSSEOTI MULTIHOLE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6. THE FOLLOWING SECTIONS WERE CORRECTED: H4. 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. IT WAS IDENTIFIED THAT ZIMMER BIOMET DEVICES WERE IMPLANTED WITH COMPETITOR DEVICES. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY FOR THESE COMBINATIONS OF DEVICES. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. PER THE IFU, IT STATES "DUAL MOBILITY HIP BEARINGS SHOULD ONLY BE USED WITH COMPATIBLE COMPONENTS THAT ARE CURRENTLY LICENSED/CLEARED FOR MARKETING IN THE COUNTRY OF USE. DO NOT USE COMPONENTS OF THE DUAL MOBILITY HIP BEARINGS WITH COMPONENTS OF ANY OTHER SYSTEM OR MANUFACTURER, UNLESS AUTHORIZED BY ZIMMER BIOMET. TO DETERMINE THE DEVICES THAT HAVE BEEN AUTHORIZED, VISIT THE ZIMMER BIOMET WEBSITE: WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM OR THE ZIMMER BIOMET ELABELING SITE." THIS COMPLAINT CANNOT BE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISASSOCIATION OF THE BEARING AND COMPETITOR. THE CUP AND BEARING WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449662 VIVACIT-E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 65627056 00889024572812

    Patients

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