BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TWIN-PEG FEMORAL MD

    MDR report key: 24302169 · Received February 10, 2026

    Report

    Report Number
    3002806535-2026-00072
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 9, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279132478
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM NAME# OXF UNI TIB TRAY SZ D LM PMA; ITEM NUMBER# 154724; LOT # 3981517. ITEM NAME# OXF ANAT BRG LT MD SIZE 4 PMA; ITEM NUMBER# 159548; LOT # 6008130. G2: FOREIGN - EVENT OCCURRED IN GERMANY. 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 LEFT KNEE REVISION SURGERY DUE TO FRACTURE AND LOOSENING OF THE FEMORAL COMPONENT. THESE COMPLICATIONS OCCURRED APPROXIMATELY 8 YEARS, 5 MONTHS, AND 28 DAYS AFTER IMPLANTATION OF A CEMENTED MEDIAL UNICOMPARTMENTAL KNEE PROSTHESIS (OXFORD UNI). ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364328 OXFORD UNI TWIN-PEG FEMORAL MD PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED NRA BIOMET UK LTD. J3967656 05019279132478

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R SEE H11 NARRATIVE.