BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI CMNTLS TIB SZ A LM

    MDR report key: 25013133 · Received April 28, 2026

    Report

    Report Number
    3002806535-2026-00173
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 28, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    00887868354816
    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: ITEM NAME#: OXF ANAT BRG LT SM SIZE 3 PMA; ITEM NUMBER#: 159540; LOT NUMBER#: 66228618. ITEM NAME#: OXF TWIN PEG CMNTLS FMRL SM; ITEM NUMBER#: 161473; LOT NUMBER#: 67115594. 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 THE PATIENT UNDERWENT REVISION FOR A MEDIAL TIBIAL PLATEAU FRACTURE FOLLOWING AN UNCEMENTED MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY. THE PATIENT WAS REVISED TO A PRK. APPROXIMATELY 49 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077186 OXF UNI CMNTLS TIB SZ A LM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED,METAL/POLYMER NRA BIOMET UK LTD. 67313144 00887868354816

    Patients

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