BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANAT BRG LT LG SIZE 3 PMA

    MDR report key: 24056355 · Received January 13, 2026

    Report

    Report Number
    3002806535-2026-00018
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 13, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786008
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: OXF TWIN-PEG CMNTD FEM LG PMA; ITEM# 161470; LOT# 334500. OXF UNI TIB TRAY SZ D LM PMA; ITEM# 154724; LOT# 131790. 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 YEAR AND ELEVEN MONTH AFTER THE INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION OF THE LEFT KNEE BEARING IMPLANT. A LARGER BEARING WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118898 OXFORD ANAT BRG LT LG SIZE 3 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. 459440 05019279786008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H