BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER RT

    MDR report key: 12643312 · Received October 15, 2021

    Report

    Report Number
    1020279-2021-07593
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 2, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556085233
    PMA / PMN Number
    K121443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED JRNY II CR LKG FEM IMP BUMPER RT CONFIRMED THE DEVICE IS BROKEN IN HALF AND BOTH PIECES WERE RETURNED. 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 AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. 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. 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 IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A JOURNEY II CR LKG FEM IMP BUMPER RIGHT IS CRACKED. IT REMAINS UNKNOWN WHEN THIS PROBLEM WAS NOTICED/OCCURRED AND IF A PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537602 JRNY II CR LKG FEM IMP BUMPER RT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 74011857 16MBG0083 00885556085233

    Patients

    Seq Age Sex Outcome Treatment
    1