BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H11 NARRATIVE

    MDR report key: 23488201 · Received November 6, 2025

    Report

    Report Number
    0001825034-2025-03505
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 9, 2025
    Report Date
    April 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K130390
    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#: 110027734, COMPR VRS GLEN PPS MIN TPR ADR; LOT#: UNKNOWN. ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 496210. ITEM#: UNKNOWN, UNKNOWN HUMERAL TRAY; LOT#: UNKNOWN. ITEM#: 115400, COMP RVS CNTRL 6.5X50MM ST/RST; LOT#: 66233624. ITEM#: 00434901013, 10MM A 130MM LENGTH HUMERAL STEM; LOT#: 66418220. ITEM#: 00435003600, 36MM VIT E LINER +0MM; LOT#: 66383530. PRODUCT ID WAS PROVIDED FOR THREE SCREWS; HOWEVER IT IS UNKNOWN WHICH OF THE THREE SCREWS FRACTURED. THEREFORE, THE FRACTURED SCREW COULD BE ANY OF THE FOLLOWING: ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 66406051. UDI: (B)(4). MANUFACTURE DATE: 2023-11-28. EXPIRATION DATE: 2033-11-28. ITEM#: 180554, COMP LK SCR 3.5HEX 4.75X35 ST; LOT#: 66528340. UDI: (B)(4). MANUFACTURE DATE: 2024-02-24. EXPIRATION DATE: 2034-02-24. ITEM#: 180556, COMP LK SCR 3.5HEX 4.75X45 ST; LOT#: 779130. UDI: (B)(4). MANUFACTURE DATE: 2021-10-06. EXPIRATION DATE: 2031-10-06. G2: FOREIGN: JAPAN. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL AS BIOHAZARD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D4, G3, G6, H2, H3, H4, H11. D4: THE EXPIRATION DATE FOR 1 POSSIBLE SCREW MENTIONED IN INITIAL REPORT IS FEB 7, 2034. (180554 LOT 66528340). H4: THE MANUFACTURING DATE FOR 1 POSSIBLE SCREW MENTIONED IN INITIAL REPORT IS FEB 7, 2024. (180554 LOT 66528340). THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR SCREW FRACTURE. IF ANY FURTHER INFORMATION IS FOUND 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 THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY USING A VRS SYSTEM APPROXIMATELY ONE (1) YEAR AND TWO (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO IMPLANT FRACTURE AND THE PRESENCE OF A POSSIBLE INFECTION. ALL IMPLANTS WERE EXPLANTED FROM THE PATIENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103 SEE H11 NARRATIVE SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. SEE H11 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.