BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR METAL IMPACTOR

    MDR report key: 24816184 · Received April 8, 2026

    Report

    Report Number
    0001825034-2026-00868
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868470103
    PMA / PMN Number
    K193373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 110031399, HMRL TRAY STD STD, LOT # 67652472. ITEM # 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 67538969. ITEM # 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 67630199. ITEM # 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 67630199. ITEM # 405889, COMP RVS 2.7MM DIA DRL, LOT # 67757486. ITEM # 405800, COMP. REV SHLDR 9 IN STEINMANN, LOT # 67757352. ITEM # 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 67524647. ITEM # 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # J8051009. ITEM # 113628, COMP PRIMARY STEM 8MM MINI, LOT # 65985471. ITEM # 110031424, CR VIVACIT-E 36MM BRNG STD, LOT # 67456641. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, D4, D9, G3, G6, H2, H4, H11. 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 PLASTIC TIP ON THE TAPER IMPACTOR TOOL BROKE WHILE IMPACTING THE GLENOSPHERE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    366819 COMPR METAL IMPACTOR SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. 840860 00887868470103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.