BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM RIGHT MEDIAL TIBIAL TRAY SIZE C

    MDR report key: 6257680 · Received January 17, 2017

    Report

    Report Number
    3002806535-2017-00029
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 19, 2016
    Report Date
    January 17, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXFORD PARTIAL KNEE SYSTEM TWIN PEG FEMORAL, CATALOG 161470, LOT 592540; OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING RIGHT MEDIAL LARGE SIZE 4MM THICK, CATALOG 159583, LOT 228280.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION OF A PARTIAL KNEE APPROXIMATELY FIVE WEEKS POST IMPLANTATION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40137 OXFORD PARTIAL KNEE SYSTEM RIGHT MEDIAL TIBIAL TRAY SIZE C PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 483150

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R