BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/+6MM

    MDR report key: 25184271 · Received May 15, 2026

    Report

    Report Number
    3002806535-2026-00192
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 15, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271199
    PMA / PMN Number
    K200959
    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: ITEM NAME# 36MM I.D. SIZE E HIGH WALL LINER; ITEM NUMBER# 30123605; LOT NUMBER# 66604030. ITEM NAME# G7 OSSEOTI 3 HOLE SHELL 52MM E; ITEM NUMBER# 110010244; LOT NUMBER# 67093882. ITEM NAME# TPRLC 133 TYPE1 BM SO 10.0; ITEM NUMBER# 51-113100; LOT NUMBER# 3995272. 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 APPROXIMATELY FIVE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO TWO DISLOCATIONS SINCE PRIMARY SURGERY. HEAD AND LINER EXCHANGED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252848 DELTA CERAMIC FEM HD 36/+6MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. 3237965 00887868271199

    Patients

    Seq Age Sex Outcome Treatment
    1