BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER LT

    MDR report key: 12656501 · Received October 19, 2021

    Report

    Report Number
    1020279-2021-07610
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 30, 2021
    Report Date
    November 3, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556422878
    PMA / PMN Number
    K121443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS CONDUCTED AND CONFIRMED THAT THE JOURNEY II CR LKG FEM IMP BUMPER LT IS FRACTURED INTO TWO PIECES. ONLY ONE PIECE WAS RETURNED. THE DEVICE SHOWS SIGNS OF SIGNIFICANT WEAR AND USE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. 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. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.ADDITIONAL INFORMATION: D3 AND D8/D9

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING TKA SURGERY, A JRNY II CR LKG FEM IMP BUMPER LT BROKE DURING IMPACTION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555086 JRNY II CR LKG FEM IMP BUMPER LT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 74011856 UNK 00885556422878

    Patients

    Seq Age Sex Outcome Treatment
    1