BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TM GLENOSPHERE

    MDR report key: 24887192 · Received April 15, 2026

    Report

    Report Number
    0001822565-2026-01296
    Event Type
    Injury
    Date Received
    April 15, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    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). D10: ITEM#: UNK TM BEARING; LOT#: UNKNOWN. E1: FULL ESTABLISHMENT NAME: (B)(6). 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) HEAD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION 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

    IT WAS REPORTED THAT A JOURNAL ARTICLE WAS OBTAINED 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 LITERATURE REPORTED ONE PATIENT, WITH ROTATOR CUFF ARTHROPATHY, HAD A REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, 0.04 YEARS POST-OPERATIVE, DISLOCATED AND UNDERWENT A REVISION OF THE POLYETHYLENE LINER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285427 UNK TM GLENOSPHERE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1