BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI CMNTLS TIB SZ A RM

    MDR report key: 25001640 · Received April 27, 2026

    Report

    Report Number
    3002806535-2026-00168
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    00887868354823
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: OXF ANAT BRG RT SM SIZE 4 PMA; ITEM# 159569; LOT# 67121232, OXF TWIN PEG CMNTLS FMRL SM; ITEM# 161473; LOT# 67236414, INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE WEEKS AFTER AN INITIAL RIGHT KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A MEDIAL PLATEAU FRACTURE. ALL COMPONENTS WERE REVISED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063352 OXFORD UNI CMNTLS TIB SZ A RM PROSTHESIS, KNEE NRA BIOMET UK LTD. 67183204 00887868354823

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.