BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOURNEY FEM IMPACT BUMPER LT

    MDR report key: 11942547 · Received June 4, 2021

    Report

    Report Number
    1020279-2021-05013
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 24, 2021
    Report Date
    July 14, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010556899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE HAS A CRACK IN THE MIDDLE AND MISSING A TAB, RENDERING THE DEVICE INOPERATIVE. THE DEVICE SHOWS SIGNS OF EXTENSIVE USE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT A JOURNEY FEM IMPACT BUMPER LT ((B)(4)) HAD A PIECE MISSING A LUG ON BOTTOM AND CRACKED. THE GROOVES THAT SLIDE ONTO THE JRNY II TKA FEM TRIAL SZ 3 LT ((B)(4)) WERE STRIPPED AND IT DID NOT LOAD PROPERLY, AND ALSO A JOURNEY ART ISRT ASSM TOOL ((B)(4)) HAD NO TENSION AND DID NOT WORK TO SEAT POLY. DEVICES OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK UP DEVICES. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835580 JOURNEY FEM IMPACT BUMPER LT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 74012821 13FM06668 03596010556899

    Patients

    Seq Age Sex Outcome Treatment
    1