BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ A STD 60MM

    MDR report key: 25315563 · Received May 28, 2026

    Report

    Report Number
    0001825034-2026-01477
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    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: ARCOS STS DIST STEM 13X250MM. ITEM: 11-301013. LOT: 943320. 32MM MOD HEAD COCR STD NECK. ITEM: 163669. LOT: J7923756. G2: FOREIGN ¿ AUSTRALIA . H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ STEM . THE PRODUCT WAS REQUESTED BUT WAS NOT RETURNED BY THE HOSPITAL AND WILL THEREFORE 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 APPROXIMATELY TWO MONTHS POST-IMPLANTATION. IT WAS NOTED, THE PROXIMAL BODY OR STEM SEEMS TO HAVE ROTATED, PLAN WAS TO REVISE PROXIMAL BODY HOWEVER THE PROXIMAL BODY COULD NOT BE MOVED, AND THE SCREW SEEMED CROSS THREADED, SO SURGEON REMOVED ENTIRE COMPONENT. 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
    276967 ARCOS CON SZ A STD 60MM PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) KWA ZIMMER BIOMET, INC. 67037909

    Patients

    Seq Age Sex Outcome Treatment
    1