BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LGN HNG DIS FEM WDG TRL S3-20M

    MDR report key: 11548603 · Received March 23, 2021

    Report

    Report Number
    1020279-2021-02300
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 24, 2021
    Report Date
    May 10, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBH
    UDI-DI
    00885556032671
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED AT THIS TIME. SO THE REPORTED EVENT COULD NOT BE CONFIRMED. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. 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. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER INVESTIGATION WARRANTED FOR THESE COMPLAINTS; 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 SET UP INSPECTION PROCESS, BEFORE CASE, IT WAS FOUND THAT THE TRIAL WAS RUSTY. THERE WAS NO PATIENT WAS INVOLVED WHEN THE ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446637 LGN HNG DIS FEM WDG TRL S3-20M PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY MBH SMITH & NEPHEW, INC. 71434222 UNKNOWN 00885556032671

    Patients

    Seq Age Sex Outcome Treatment
    1