BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LGN OFFSET COUPLER TRIAL 4MM

    MDR report key: 11683739 · Received April 19, 2021

    Report

    Report Number
    1020279-2021-03156
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 23, 2021
    Report Date
    June 7, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBH
    UDI-DI
    03596010547972
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED AT THIS TIME. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. THE DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES AND CLEANING CYCLES. AS PLASTICS ARE VULNERABLE AND CRACK MAY HAVE INITIATED DURING USE AND POSSIBLE CAUSES COULD BE DUE TO THE HEATING AND COOLING ASSOCIATED WITH AUTOCLAVING OR PROLONGED USE. 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. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR 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 A LEGION OFFSET COUPLER TRIAL 4MM AND A LGN SCW POS WG TRL 5M SZ5-6LG WERE UNABLE TO ENGAGE THE LOCKING MECHANISM. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582938 LGN OFFSET COUPLER TRIAL 4MM PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY MBH SMITH & NEPHEW, INC. 71434304 UNK 03596010547972

    Patients

    Seq Age Sex Outcome Treatment
    1