BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING MEDIUM LEFT 5MM THICK

    MDR report key: 6357197 · Received February 24, 2017

    Report

    Report Number
    3002806535-2017-00088
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 24, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS ¿ OXFORD MEDIUM FEMORAL CATALOG 154926 LOT 2466504; OXFORD TIBIAL TRAY CATALOG 166578 LOT 2160684. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2012-00331 / 3002806535-2017-00088).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST IMPLANTATION DUE TO DISLOCATION. THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139425 OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING MEDIUM LEFT 5MM THICK PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2444061

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R