BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 15X150MM SPL TPR DIST

    MDR report key: 25230117 · Received May 20, 2026

    Report

    Report Number
    0001825034-2026-01351
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304474178
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    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). H10: ARCOS CON SZ C STD 60MM. ITEM: 11-301303, LOT: 65710916. G7 OSSEOTI MULTIHOLE 58MM G. ITEM: 110010267, LOT: 7196540. G7 HI-WALL E1 LINER 36MM G. ITEM: 010000937, LOT: 7210981. G7 SCREW 6.5MM X 30MM. ITEM: 010000999, LOT: 7389732. DELTA CERAMIC FEM HD 36/-3MM. ITEM: 650-0660, LOT: 3095592. G2: FOREIGN ¿ AUSTRALIA. H6: SUGGESTED 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 THREE YEARS POST-IMPLANTATION DUE TO PAIN AND RADIOLUCENCY OF COMPONENT. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228813 ARCOS 15X150MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 65750703 00880304474178

    Patients

    Seq Age Sex Outcome Treatment
    1