BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP AUG MINI BSPLT W TPR MD

    MDR report key: 23843542 · Received December 18, 2025

    Report

    Report Number
    0001825034-2025-04076
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304993242
    PMA / PMN Number
    K172502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-1020929: D10: ITEM # 115394, COMP RVS CNTRL 6.5X20MM ST/RST, LOT # 67015756. ITEM # 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 67299910. ITEM # 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 67286539. ITEM # 115313, COMP RVSR SHLDR GLNSP +3 36MM, LOT # J7912269. ITEM # 113632, COMP PRIMARY STEM 12MM MINI, LOT # 65559371. ITEM # 110031403, MINI TRAY +5MM COCR +3 OFFSET, LOT # 66058388. ITEM # 110031425, CR VIVACIT-E 36MM BRNG +3, LOT # 66874216. ITEM # 405889, COMP RVS 2.7MM DIA DRL, LOT # 67133741. ITEM # 405800, COMP. REV SHLDR 9 IN STEINMANN, LOT # 66875013. ITEM # 406669, STN PN THD TIP .125X2.5IN 2PK, LOT # 65922885. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY REVERSE SHOULDER PROCEDURE. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS AND 19 DAYS POST IMPLANTATION THE PATIENT WAS PRESENTING WITH A PAINFUL SHOULDER AND AN X-RAY AND CT SCAN SHOWED GLENOID COMPONENT MIGRATION. IT WAS NOTED THAT THE PATIENT HAD PRIOR NEUROLOGIC PATHOLOGY AND POOR BONE QUALITY. THE PATIENT PLANS TO BE REVISED WHERE THE GLENOID COMPONENTS WILL BE REMOVED WHILE DISCUSSING FURTHER OPTIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423634 COMP AUG MINI BSPLT W TPR MD PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 67016829 00880304993242

    Patients

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