BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS MODULAR REVISION HIP SYSTEM

    MDR report key: 25184332 · Received May 15, 2026

    Report

    Report Number
    0001825034-2026-01310
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 29, 2024
    Report Date
    May 15, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00700006620 LOT# 64985497 66MM CUP SIZE REVISION SHELL. CAT# 00713306658 LOT# 3002378 PROVISIONAL SHORT FLANGE CAGE. CAT# 00625006540 LOT# J7629854 BONE SCREW . CAT# 00625006515 LOT# J7131464 BONE SCREW. CAT# 00625006515 LOT# J7583492 BONE SCREW. CAT# 00625006520 LOT# 63044691 BONE SCREW. CAT# 00712306658 LOT# 3089341 ACETABULAR REVISION SYSTEM - CAGE. CAT# 00625006550 LOT# 64143387 BONE SCREW. CAT# 00625006515 LOT# J7583489 BONE SCREW. CAT# 00625006540LOT# J7622086 BONE SCREW. CAT# 00625006520 LOT# 65632422 BONE SCREW. CAT# 00625006520 LOT# J7576006 BONE SCREW. CAT# 20123604 LOT# 65051472 36MM I.D. SIZE D HIGH WALL LINER. CAT# 650-0662 LOT# 3144899 DELTA CERAMIC FEM HD 36/+3MM. CAT# 110034355 LOT# AX48CA0604 REFOBACIN BC R 1X40 US. CAT# 00504905500 LOT# 66090710 W/(2) ALLEN MEDULLARY CEMENT PLUGS. H6: PROPOSED CODE - MECHANICAL (G04) ¿ STEM 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 APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27517 ARCOS MODULAR REVISION HIP SYSTEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 66095192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H| L