BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS STS DIST STEM 24X250MM

    MDR report key: 23748764 · Received December 8, 2025

    Report

    Report Number
    0001825034-2025-03897
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 13, 2025
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304474550
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4 (EXPIRATION DATE, UDI #), G3, G6, H2, H3, H4, H6, H11. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE VISIT 2 AP RADIOGRAPH SHOWS RADIOLUCENCY AT THE DISTAL FEMORAL STEM METAL-BONE INTERFACES CONSISTENT WITH LOOSENING. FINDINGS OF LOOSENING OF THE DISTAL FEMORAL STEM ARE CONSISTENT WITH INSTABILITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) D10: 11-301353 ARCOS CON SZ C HI 80MM 071120. G2: FOREIGN: AUSTRALIA. SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 15 YEARS POST IMPLANTATION DUE TO IMPLANT FRACTURE OF FEMORAL COMPONENT. THE REVITAN STEM WAS EXCHANGED ALONG WITH COMPETITOR HEAD AND LINER. COMPETITOR CABLES USED FOR OSTEOTOMY. THE PATIENT WAS IMPLANTED WITH AN ARCOS STEM. THE PATIENT WAS REVISED A SECOND TIME DUE TO IMPLANT SUBSIDENCE AND INSTABILITY. THE ARCOS PRODUCTS WERE EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566793 ARCOS STS DIST STEM 24X250MM PROSTHESIS, HIPS KWA ZIMMER BIOMET, INC. N/A 088020 00880304474550

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention| H SEE H11 NARRATIVE.