BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING

    MDR report key: 6216297 · Received December 30, 2016

    Report

    Report Number
    3002806535-2016-00930
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 29, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4), MEDICAL PRODUCT - PN: 154926 LN: 3861276 CEMENTLESS MEDIUM FEMUR, PN: 166576 LN: 3808969 CEMENTLESS LEFT MEDIAL TIBIAL TRAY SIZE D.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE 19 DAYS POST-IMPLANTATION DUE TO DISLOCATION OF THE BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865721 OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 3843793

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R