BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL®

    MDR report key: 24949833 · Received April 22, 2026

    Report

    Report Number
    0001822565-2026-01353
    Event Type
    Injury
    Date Received
    April 22, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN 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). 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. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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

    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 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. THE LITERATURE REPORTED RADIOGRAPHIC EVIDENCE OF GLENOID LOOSENING WITH MIGRATION IN TWO CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13650 TRABECULAR METAL® PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1