BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS II SPC F/E SZ GDE

    MDR report key: 12800899 · Received November 11, 2021

    Report

    Report Number
    1020279-2021-08103
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    September 9, 2020
    Report Date
    March 3, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRY
    UDI-DI
    00885556059951
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE COULD NOT CONFIRM THE STATED FAILURE MODE. THE DIMENSIONAL EVALUATION CONFIRMED THE STATED FAILURE MODE. THE CONNECTING FEATURE WAS FOUND TO BE OVERSIZE ON THE DEVICE. A REVIEW OF COMPLAINT HISTORY BASED ON THE HISTORICAL DATA REVEALED SIMILAR EVENTS FOR THE LISTED BATCH, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS 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 HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. ASSESSMENT OF HISTORICAL ESCALATED CASES CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS DEVICE AND FAILURE MODE. AS THE DEVICE WAS FOUND TO BE OUT OF TOLERANCE PER DIMENSIONAL SPECIFICATION, THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD BE CORROBORATED. A POTENTIAL PROBABLE CAUSE COULD BE BUT IS NOT LIMITED TO A MANUFACTURING DEFICIENCY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS INDICATED. THE EVENT IS BEING ADDRESSED THROUGH THE SUPPLIER QUALITY TEAM. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE COULD NOT CONFIRM THE STATED FAILURE MODE. 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. THE DIMENSIONAL EVALUATION CONFIRMED THE STATED FAILURE MODE. THE CONNECTING FEATURE WAS FOUND TO BE OVERSIZE ON THE DEVICE, SO (B)(4) WAS INITIATED AND ASSIGNED TO SUPPLIER QUALITY FOR FURTHER INVESTIGATION. AT THIS TIME, WE HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A POTENTIAL PROBABLE CAUSE COULD BE BUT IS NOT LIMITED TO A MANUFACTURING DEFICIENCY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. THIS IS AN ISOLATED EVENT THAT IS CURRENTLY BEING MONITORED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SURGERY, THE GENESIS II SPC F/E SZ GDE WAS FOUND BROKEN: THE ROD WOULD NOT ATTACH PROPERLY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED. ON INVESTIGATION RESULTS IT WAS FOUND THAT THE CONNECTING FEATURE WAS OVERSIZE ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699227 GENESIS II SPC F/E SZ GDE PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY SMITH & NEPHEW, INC. 71933043 17KCT0001 00885556059951

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown