BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 32MM RNGLOC LNR HWALL 23

    MDR report key: 24829388 · Received April 9, 2026

    Report

    Report Number
    0001825034-2026-00893
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 32 MM MOD HEAD COCR STD NECK, ITEM: 163669, LOT: 64866328. G2: FOREIGN; AUSTRALIA. THE PRODUCT WAS REQUESTED BUT WAS NOT RETURNED BY THE HOSPITAL; THEREFORE, IT WILL NOT BE SENT TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, IT WAS NOTED THAT THE HEAD AND LINER WERE REVISED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21841 ARCOM 32MM RNGLOC LNR HWALL 23 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 251520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.