BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOID

    MDR report key: 22176147 · Received June 10, 2025

    Report

    Report Number
    0001822565-2025-01773
    Event Type
    Injury
    Date Received
    June 10, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM #: UNKNOWN, UNKNOWN GLENOID; LOT #: UNKNOWN. G2: FOREIGN: JAPAN. LITERATURE CITATION: HIJIKATA, K., SHIOZAKI, H., SOMEYA, K., & KITAHARA, H. (2024). TREATMENT OUTCOMES OF PATIENTS WITH AT LEAST 3 YEARS OF FOLLOW-UP AFTER ANATOMICAL TOTAL SHOULDER ARTHROPLASTY. THE SHOULDER JOINT, 48(1), 147-150. IT SHOULD BE NOTED THAT THE CITED JOURNAL ARTICLE WAS NOT PROVIDED BY THE REPORTER, AND WAS UNABLE TO BE FOUND, THUS IT IS NOT ATTACHED. H3: 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO IMPLANT LOOSENING.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355638 UNKNOWN GLENOID SHOULDER IMPLANT/EXTREMITIES PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE