BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIDUS® STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, M

    MDR report key: 21482987 · Received February 27, 2025

    Report

    Report Number
    0009613350-2025-00087
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    December 18, 2024
    Report Date
    March 12, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K171858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED, AND A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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. SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 42-15 ITEM# 0104555420, LOT# 2922208. BIOMET BC R 1X40 US, ITEM# 110035368, LOT# Y11BAA2101. SIZE 1 3-PEG MONOBLOCK CEMENTED GLENOID, ITEM# SAGL2021, LOT# 64803705. KEEL SPONGE SINGLE USE ONLY ITEM# 00430103401, LOT# 64499574. COMP RVS 9 IN STNMN PIN SF, ITEM# 405800-00, LOT# 495090. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT SHOULDER ARTHROPLASTY AND SUBSEQUENTLY, APPROXIMATELY 3 YEARS POST IMPLANTATION, UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS. SIDUS STEMLESS COMPONENT AND AN ALLIANCE GLENOID WERE REVISED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029971 SIDUS® STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, M SHOULDER PROSTHESIS/EXTREMITIES LZO ZIMMER GMBH 3056797

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| H SEE H11 NARRATIVE.