BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 RIGHT MEDIAL TIBIAL TRAY STANDARD SIZE D

    MDR report key: 6301509 · Received February 3, 2017

    Report

    Report Number
    3002806535-2017-00062
    Event Type
    Death
    Date Received
    February 3, 2017
    Date of Event
    September 29, 2016
    Report Date
    February 3, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXFORD RIGHT BEARING SIZE 3 CATALOG 159582 LOT 1310716; OXFORD LARGE FEMORAL CATALOG 154602 LOT 1382562.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN A CLINICAL STUDY EXPIRED DUE TO INJURIES CAUSED BY A FALL APPROXIMATELY NINE YEARS POST IMPLANTATION; THE CAUSE OF THE FALL IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84934 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 RIGHT MEDIAL TIBIAL TRAY STANDARD SIZE D PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 1276295

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death SEE H10