BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS II SPC F/E SZ GDE

    MDR report key: 11683756 · Received April 19, 2021

    Report

    Report Number
    1020279-2021-03166
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 25, 2021
    Report Date
    May 27, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBH
    UDI-DI
    00885556059951
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE PRODUCT ANALYSIS AND THE REPORTED EVENT COULD NOT BE CONFIRMED AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF THE COMPLAINT HISTORY ON THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED FAILURE MODE WITH THE SAME BATCH NUMBER. 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. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE GENESIS II SPC F/E SZ GDE AND JOURNEY F/E GAP BAL SZ GDE HEX BOLT THAT HOLD THE MECHANISM TOGETHER WERE STRIPPED AND WILL NOT SEAT THE INSERTION PEG FLUSH WITH THE REST OF THE MECHANISM. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED (ABOUT 5 MINUTES), AS THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP DEVICE. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583959 GENESIS II SPC F/E SZ GDE PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY MBH SMITH & NEPHEW, INC. 71933043 13DCT0004 00885556059951

    Patients

    Seq Age Sex Outcome Treatment
    1