BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD TIBIAL TRAY SIZE AA LM

    MDR report key: 6214473 · Received December 29, 2016

    Report

    Report Number
    3002806535-2016-00923
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 28, 2016
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT PRODUCTS: PN: 161468 LN: 301760 OXFORD TWIN-PEG FEMORAL COMPONENT. PN: 159542 LN: 160660 OXFORD BEARING SIZE 5.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE DUE TO LOOSE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863714 OXFORD TIBIAL TRAY SIZE AA LM PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 517270

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R