BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER RT

    MDR report key: 12418117 · Received September 2, 2021

    Report

    Report Number
    1020279-2021-06704
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 29, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556085233
    PMA / PMN Number
    K121443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    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 RETURNED JRNY II CR LKG FEM IMP BUMPER RT IS BROKEN IN HALF. THIS DEVICE ALSO HAS EXTENSIVE WEAR USAGE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF THE REPORTED EVENT. 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. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A TKA, A JRNY II CR LKG FEM IMP BUMPER LT AND JRNY II CR LKG FEM IMP BUMPER RT CRACKED INTO TWO PIECES DUE TO EXCESSIVE WEAR AND TEAR. THIS HAPPENED AFTER BEING USED IN PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312467 JRNY II CR LKG FEM IMP BUMPER RT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 74011857 18FBG0014 00885556085233

    Patients

    Seq Age Sex Outcome Treatment
    1