BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 25298225 · Received May 27, 2026

    Report

    Report Number
    3002806535-2026-00198
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271168
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM NAME# G7 SCREW 6.5 MM X 30 MM; ITEM NUMBER# 010000999; LOT NUMBER# 7389732. ITEM NAME# G7 HI-WALL E1 LINER 36 MM G; ITEM NUMBER# 010000937; LOT NUMBER# 7210981. ITEM NAME# G7 OSSEOTI MULTIHOLE 58 MM G; ITEM NUMBER# 110010267; LOT NUMBER# 7196540. ITEM NAME# ARCOS CON SZ C STD 60 MM; ITEM NUMBER# 11-301303; LOT NUMBER# 65710916. ITEM NAME# ARCOS 15 X 150 MM SPL TPR DIST; ITEM NUMBER# 11-300815; LOT NUMBER# 65750703. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. 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 THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO PAIN AND RADIOLUCENCY OF THE COMPONENT. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289603 DELTA CERAMIC FEM HD 36/-3MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. 3095592 00887868271168

    Patients

    Seq Age Sex Outcome Treatment
    1