BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP AUG MINI BSPLT W TPR MD

    MDR report key: 22238194 · Received June 17, 2025

    Report

    Report Number
    0001825034-2025-01766
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 23, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K172502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: MEDICAL PRODUCTS: ITEM#: 115316, COMP RVRS SHLDR GLNSP +6 36MM; LOT#: 943630. G2: FOREIGN: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DECARDED. 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 AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. THE FOLLOWING SECTION WAS CORRECTED: D10. D10: MEDICAL PRODUCTS: ITEM #: 110032420, COMP AUG MINI BSPLT W TPR MD; LOT #: 66747368. 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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A REVERSE-TYPE RIGHT SHOULDER ARTHROPLASTY IS PRESENT. THE GLENOSPHERE IS SEPARATED FROM THE GLENOID BASEPLATE. THERE IS A RESULTING DISLOCATION OF THE IMPLANTS. THE HUMERAL STEM IS INCOMPLETELY VISUALIZED. NO FRACTURE IS IDENTIFIED. 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 THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AND FIVE (5) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY ONE (1) MONTH AGO DUE TO THE IMPLANTS DISASSOCIATING. IT IS UNKNOWN AT THIS TIME WHAT CAUSED THE IMPLANTS TO DISASSOCIATE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    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
    1645971 COMP AUG MINI BSPLT W TPR MD SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 64155087

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Hospitalization| R SEE H11 NARRATIVE