BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 24179959 · Received January 26, 2026

    Report

    Report Number
    0001825034-2026-00205
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    December 31, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 405889, COMP RVS 2.7MM DIA DRL, LOT # 67339898. ITEM # 405883, COMP RVS 3.2MM DRL, LOT # 67405007. ITEM # 110003484, ACCESS 3.2MM THD STEINMANN 9, LOT # 67257664. ITEM # 110031419, CR PROLONG 36MM BRNG +3, LOT # 67338871. ITEM # 113637, COMP PRIMARY STEM 17MM MINI, LOT # 65218335. ITEM # 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # J7960066. ITEM # 110031400, MINI TRAY +5MM COCR +0 OFFSET, LOT # 67063667. ITEM # 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 67627424. ITEM # 180558, COMP NLK SCR 3.5HEX 4.75X20 ST, LOT # 67403907. ITEM # 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, LOT # 67422159. ITEM # 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 67418137. ITEM # 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 67420035. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT SHOULDER REVISION APPROXIMATELY 44 DAYS POST IMPLANTATION DUE TO TAPER DISASSOCIATION FROM BASEPLATE. 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
    245107 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 67158396 00880304532465

    Patients

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