BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER RT

    MDR report key: 10338326 · Received July 29, 2020

    Report

    Report Number
    1020279-2020-03556
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 9, 2020
    Report Date
    November 12, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556085233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE DEVICE, INTENDED USE IN TREATMENT, WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION CONFIRMED THE JRNY II CR LKG FEM IMP BUMPER RT IS BROKEN INTO TWO PIECES. THE DEVICE SHOWS SIGNIFICANT SIGNS OF WEAR/USAGE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. 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. THIS IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. 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. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JOURNEY II CR LKG FEM IMP BUMPER RT IS CRACKED IN HALF. THERE WAS NO CASE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805887 JRNY II CR LKG FEM IMP BUMPER RT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 74011857 13FBG0027 00885556085233

    Patients

    Seq Age Sex Outcome Treatment
    1