BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS

    MDR report key: 24686585 · Received March 25, 2026

    Report

    Report Number
    0001825034-2026-00692
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    September 17, 2025
    Report Date
    May 15, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    NI
    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

    (B)(4). D10: ASSOCIATED PRODUCT INFORMATION, PART (LOT): UNKNOWN PROXIMAL BODY BODY 42MM (UNKNOWN); UNKNOWN GLENOSPHERE 41+0MM (UNKNOWN); UNKNOWN TRAY +10MM (UNKNOWN); UNKNOWN POLY 44-41+3MM (UNKNOWN). E1: FULL ESTABLISHMENT NAME: (B)(6). G2: LITERATURE - VAUCLIN, C., SHEPPARD, A., MASSEY, P., ADKINS, J., CALLANAN, M., LOBAO, M., & BARTON, R. S. (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, 10(1), 101381. HTTPS://DOI.ORG/10.1016/J.JSEINT.2025.09.003 H6: PROPOSED ANNEX G CODE - MECHANICAL (G04) - STEM. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE REPORTER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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. OVER APPROXIMATELY EIGHT YEARS, THE ARTICLE REVIEWED A TOTAL OF 28 PATIENTS WHO UNDERWENT REVISION SHOULDER ARTHROPLASTY RECONSTRUCTION. THE STUDY POPULATION HAD A MEAN AGE OF 76 YEARS AT TIME OF SURGERY (RANGE, 60-91 YEARS); (7 MALES/21 FEMALES). FOLLOW-UP WAS CONDUCTED AT 6-WEEK, 12-WEEK, 6-MONTH, 1-YEAR, AND 2-YEAR INTERVALS, WITH A MEAN LENGTH OF FOLLOW-UP FOR 2.8 YEARS (RANGE, 2.0-3.5 YEARS). THE LITERATURE REPORTED THAT ONE PATIENT REQUIRED A REVISION DUE TO LOOSENING OF THE CEMENTED HUMERAL STEM NINE MONTHS POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184019 COMPREHENSIVE SRS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1