BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE BALANCER THRD IM ROD

    MDR report key: 13636111 · Received March 1, 2022

    Report

    Report Number
    1020279-2022-00934
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 28, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRY
    UDI-DI
    03596010592101
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    SECTION H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A REVIEW OF COMPLAINT HISTORY FOR THE PREVIOUS 12 MONTHS DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO 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. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. 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 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 · 0

    IT WAS REPORTED, DURING SET UP, IT WAS NOTICED THAT THE THREADS FROM THE KNEE BALANCER THRD IM ROD HAVE BROKEN OFF INTO THE GENESIS II SPC F/E SZ GDE COMPONENT. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH BACK-UP DEVICES INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795203 KNEE BALANCER THRD IM ROD PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY SMITH & NEPHEW, INC. 71933042 UNK 03596010592101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown