BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY BCS PAT RESRF RD 41 MM STD

    MDR report key: 6840868 · Received September 4, 2017

    Report

    Report Number
    1020279-2017-00694
    Event Type
    Malfunction
    Date Received
    September 4, 2017
    Date of Event
    April 13, 2014
    Report Date
    November 7, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010554567
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LATER ON PATIENT HAD A PATELLAR FRACTURE ON CONTRALATERAL ANATOMY DUE TO TRAUMA, WHICH HAS BEEN REPORTED VIA 1020279-2017-00692.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA RECEIVED FROM THE STUDY SITE INDICATED THAT NO REMEDIAL THERAPY WAS DONE TO SOLVE THIS PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD FRACTURED LEFT KNEE PATELLA AS A RESULT OF TRAUMA. IT WAS REPORTED THAT ACTION TAKEN TO SOLVE THIS PROBLEM WAS A SURGICAL PROCEDURE, BUT ALSO THAT THIS PATIENT HAS NOT HAD REVISION SURGERY OF THE LEFT KNEE.

    Description of Event or Problem · 1

    PATIENT WAS ADVISED TO USE CRUTCHES AS WELL AS KNEE IMMOBILISER AND TO REPORT TO ORTHOPEDICS AS PER PRE-SCHEDULED APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620806 JRNY BCS PAT RESRF RD 41 MM STD PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 13CM05013 03596010554567

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other