BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER SYSTEM VIVACIT-E- HIGHLY CROSSLINKED POLYETHYLENE

    MDR report key: 22663300 · Received July 30, 2025

    Report

    Report Number
    0001822565-2025-02719
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    June 27, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868231551
    PMA / PMN Number
    K181611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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/CORRECTED: B4; B5; D1; D2; G1; G3; G6; H1; H2; H3; H4; H6. D10: ASSOCIATED PRODUCT INFORMATION, PART (LOT): -010000589 (161220), -110031402 (64808960), -180552 (60640), -113612 (64877512), -180553 (246180), -405889 (834470), -110031424 (64862407), -115395 (105040), -405800 (94530), -405883 (923930), -180551 (482110). THE REPORTED EVENT IS NOT CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE PHOTOS PROVIDED ARE SCREENSHOTS OF THE PART NUMBERS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND THAT 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: ASSOCIATED PRODUCT INFORMATION, PART (LOT): - 115310(927920). G2: FOREIGN - THE EVENT OCCURRED IN AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION SINCE IT WAS NOT RETURNED BY THE HOSPITALN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD A PRIMARY SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 3 YEARS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A DISLOCATION. THE HUMERAL HEAD AND GLENOID COMPONENTS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514728 COMPREHENSIVE REVERSE SHOULDER SYSTEM VIVACIT-E- HIGHLY CROSSLINKED POLYETHYLENE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. 64862407 00887868231551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R