BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER RT

    MDR report key: 10143611 · Received June 11, 2020

    Report

    Report Number
    1020279-2020-02326
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 14, 2020
    Report Date
    September 14, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K121443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THE STATED FAILURE MODE WAS CONFIRMED THROUGH A VISUAL INSPECTION OF THE RETURNED JRNY II CR LKG FEM IMP BUMPER RT. THE BUMPER FRACTURED INTO TWO PIECES. ONLY ONE PIECE WAS RETURNED. THE DEVICE WAS MANUFACTURED IN 2018. THE DEVICE EXHIBITS SIGNS OF SIGNIFICANT USE AND WEAR. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCH WITH THE SAME FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES AND CLEANING CYCLES. AS PLASTICS ARE VULNERABLE AND CRACK MAY HAVE INITIATED DURING USE AND POSSIBLE CAUSES COULD BE DUE TO THE HEATING AND COOLING ASSOCIATED WITH AUTOCLAVING OR PROLONGED USE. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THIS JOURNEY II CR LKG FEM IMP BUMPER RIGHT BROKE UPON IMPACTING. THERE WAS A REPLACEMENT INSTRUMENT READILY AVAILABLE AND THERE WAS NO DELAY NOR HARM TO THE PATIENT. ALL PARTS WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609667 JRNY II CR LKG FEM IMP BUMPER RT PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1