BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL STEM

    MDR report key: 24700263 · Received March 26, 2026

    Report

    Report Number
    0001822565-2026-00959
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    September 17, 2025
    Report Date
    May 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). G2: LITERATURE - VAUCLIN, CAMERON ET AL. (2025). CLINICAL OUTCOMES OF MODULAR SEGMENTAL MEGAPROSTHESIS FOR REVISION SHOULDER ARTHROPLASTY WITH SEVERE PROXIMAL HUMERUS BONE LOSS AT A MINIMUM TWO YEAR FOLLOW-UP. JSES INTERNATIONAL, VOLUME 10, ISSUE 1, 101381. HTTPS://DOI.ORG/10.1016/J.JSEINT.2025.09.003. H6: PROPOSED ANNEX G CODE: MECHANICAL (G04) - STEM. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS OBTAINED THAT REPORTED A RETROSPECTIVE STUDY FROM THE USA. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE FUNCTIONAL OUTCOMES, PAIN, AND SURVIVORSHIP OF MODULAR SEGMENTAL MEGAPROSTHESIS UTILIZED FOR REVISION, REVERSE TOTAL SHOULDER ARTHROPLASTY FOLLOWING FAILED SHOULDER ARTHROPLASTY IN THE SETTING OF SEVERE PROXIMAL HUMERAL BONE LOSS. DURING AN 8-YEAR TIMESPAN, THE ARTICLE REVIEWED A TOTAL OF 28 PATIENTS WHO UNDERWENT REVISION SHOULDER ARTHROPLASTY RECONSTRUCTION. THE LITERATURE REPORTED ONE PATIENT REQUIRED A REVISION DUE TO LOOSENING OF THE PRESS-FIT HUMERAL STEM TWELVE MONTHS POST-OPERATIVE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351603 UNKNOWN HUMERAL STEM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED MBF ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1