BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER LT

    MDR report key: 10113408 · Received June 3, 2020

    Report

    Report Number
    1020279-2020-01958
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 6, 2020
    Report Date
    July 2, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556422878
    PMA / PMN Number
    K121443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FIND ADDITIONAL INFORMATION RECEIVED FOR THIS CASE IN SECTIONS: LOT NUMBER AND EXPIRATION DATE) AND DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION CONFIRMED THE JRNY II CR LKG FEM IMP BUMPER LT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY, THE JOURNEY II CR LKG FEMORAL IMPACTOR BUMPER LEFT BROKE EXTERNAL TO THE PATIENT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579925 JRNY II CR LKG FEM IMP BUMPER LT PRSTHSS, KN, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL/PLYMR JWH SMITH & NEPHEW, INC. 13FBG0019 00885556422878

    Patients

    Seq Age Sex Outcome Treatment
    1