BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL STEM

    MDR report key: 24932843 · Received April 20, 2026

    Report

    Report Number
    0001825034-2026-00996
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    October 2, 2025
    Report Date
    April 27, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: B4, G3, G6, H2, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). A2: MEAN AGE OF 63.5 YEARS AT TIME OF SURGERY (RANGE, 56.5 TO 72). G2: LITERATURE - WATANABE S, KAIBARA T, FEELEY BT, ZHANG AL, LANSDOWN DA, MA CB. (2025). SURVIVAL RATE AND OUTCOMES OF REVERSE TOTAL SHOULDER ARTHROPLASTY WITH A MINIMUM TEN-YEAR FOLLOW-UP USING A TRABECULAR METAL IMPLANT. BONE JT OPEN. 2025 OCT 2;6(10):1171-1178. DOI: 10.1302/2633-1462.610.BJO-2025-0147.R1. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - STEM. 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 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS OBTAINED ON 26-MAR-2026 THAT REPORTED A RETROSPECTIVE STUDY FROM USA. THE PURPOSE OF THE STUDY WAS TO REPORT ON THE RESULTS OF RTSA USING A SINGLE IMPLANT, POROUS-COATED TM IMPLANT, FROM A SINGLE INSTITUTION (UNIVERSITY OF CALIFORNIA, USA) WITH A MINIMUM FOLLOW-UP OF TEN YEARS. THE STUDY REVIEWED 60 REVERSE TOTAL SHOULDER ARTHROPLASTIES (RTAS) IN 58 PATIENTS, INCLUDING 57 WITH ASES SCORES AND 40 RTSAS (38 PATIENTS) WITH RADIOGRAPHS. ALL PROCEDURES WERE PERFORMED BETWEEN OCTOBER 2007 AND JULY 2013 USING A ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM. A DELTOPECTORAL APPROACH WAS USED ALONG WITH A CEMENTED TM-COATED HUMERAL COMPONENT, TM-BACK GLENOSPHERE, TWO SUPERIOR AND INFERIOR LOCKING SCREWS, AND AN ELEVATED POLYETHYLENE LINER. THE STUDY POPULATION HAD A MEAN AGE OF 63.5 YEARS AT TIME OF SURGERY (RANGE, 56.5 TO 72); 33 MALES/27 FEMALES; BMI AVERAGE OF 27.7 (RANGE, 24.1 TO 31.5). FOLLOW-UP WAS CONDUCTED FOR AN AVERAGE LENGTH OF 11 YEARS WITH A MINIMUM TEN-YEAR FOLLOW-UP. IT WAS REPORTED THROUGH A JOURNAL ARTICLE THAT RADIOGRAPHIC EVIDENCE OF HUMERAL COMPONENT LOOSENING WAS OBSERVED IN THREE CASES FOLLOWING REVERSE TOTAL SHOULDER ARTHROPLASTY AT APPROXIMATELY TEN OR MORE YEARS POST-IMPLANTATION. THE CASES WERE IDENTIFIED DURING LONG-TERM RADIOGRAPHIC FOLLOW-UP WITHIN A RETROSPECTIVE STUDY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586314 UNKNOWN HUMERAL STEM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1