BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIVACIT-E

    MDR report key: 23027073 · Received September 11, 2025

    Report

    Report Number
    0001822565-2025-03369
    Event Type
    Injury
    Date Received
    September 11, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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: B5; B6; G3; H6 HEALTH IMPACT CODE. THE FOLLOWING SECTIONS WERE CORRECTED: H6 CLINICAL CODES REMOVE E161202, E2123, AND E1901 AND ADD E161201. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 0100561317 LOT: 3122141 WAGNER CONE PROSTHESIS. CAT: 00877503603 LOT: 3156929 BIOLOX® DELTA, CERAMIC FEMORAL HEAD. CAT: 110010243 LOT: 65862844 G7 OSSEOTI 3 HOLE SHELL. 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

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A HIP REVISION DUE TO LOOSENING WITH INFECTION UNLIKELY. PATIENT REPORTS PAIN, SWELLING, AND TROCHANTERIC BURSITIS DIAGNOSIS. REVISION IS PLANNED.ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A HIP REVISION DUE TO BACTERIAL INFECTION AND LOOSENING. PATIENT REPORTS PAIN, SWELLING, AND TROCHANTERIC BURSITIS DIAGNOSIS. REVISION IS PLANNED BUT HAS NOT YET TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540940 G7 VIVACIT-E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 66179347

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other