BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JRNY BCS PAT RESRF RD 35 MM STD

    MDR report key: 6829616 · Received August 30, 2017

    Report

    Report Number
    1020279-2017-00674
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    December 5, 2015
    Report Date
    February 26, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556169919
    PMA / PMN Number
    K042515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. PLEASE SEE ATTACHED FILE FOR OUR RESULTS OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE 510K ASSOCIATED WITH CONCOMITANT DEVICES: K111711.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT DEVELOPED A PRE PATELLAR EFFUSION WHICH WAS LARGER AND DID NOT DIMINISH WITH TIME OR COMPRESSION. THEREFORE A BURSECTOMY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD CHRONIC KNEE SWELLING THAT RESULTS IN A SURGICAL INTERVENTION: BURSECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610697 JRNY BCS PAT RESRF RD 35 MM STD PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH SMITH & NEPHEW, INC. 12BM07463 00885556169919

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R JOURNEY TIBIA BASE NP RT SZ 5, (B)(4)| JRNY BCS PAT RESRF RD 35 MM STD, (B)(4)| JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM, (B)(4)