BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREW

    MDR report key: 25322063 · Received May 28, 2026

    Report

    Report Number
    0009613350-2026-00267
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    October 2, 2025
    Report Date
    May 26, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D6A. IMPLANT DATE: BETWEEN (B)(6) 2007, AND (B)(6) 2013. D10. UNKNOWN TM GLENOID ITEM# UNKNOWN LOT# UNKNOWN. 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. 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 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. 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. THE LITERATURE REPORTED RADIOGRAPHIC EVIDENCE OF GLENOID LOOSENING WITH MIGRATION IN TWO CASES. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545979 UNKNOWN SCREW IMPLANT, EXTREMITY. HRS ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1