BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGION CR OXIN FEM SZ6 LT

    MDR report key: 7113394 · Received December 13, 2017

    Report

    Report Number
    1020279-2017-01236
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    December 7, 2017
    Report Date
    March 18, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556030202
    PMA / PMN Number
    K043440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. [(B)(4)].

    Additional Manufacturer Narrative · 1

    THE DEVICE INDICATED IN THIS REPORT IS PART OF A CONSTRUCT. PLEASE REFER TO MDR 1020279-2017-01233, THE MASTER COMPLAINT. OTHER RELATED MDR¿S 1020279-2017-01234, 1020279-2017-01235.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED WITH PAIN AND UNDERWENT ASPIRATION OF THE KNEE AND NERVE BLOCK ABLATION IN THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892391 LEGION CR OXIN FEM SZ6 LT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH SMITH & NEPHEW, INC. 16EM04536 00885556030202

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 71420168/16LM09514| 71420576/16MM01226| 71420576/16MM01226