BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN GENESIS II TOTAL KNEE FEM COMP COCR CEM

    MDR report key: 14674654 · Received June 13, 2022

    Report

    Report Number
    1020279-2022-02908
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    January 1, 1901
    Report Date
    July 13, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRY
    PMA / PMN Number
    K121393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, NO RELEVANT SUPPORTING CLINICAL INFORMATION COULD BE PROVIDED TO ASSIST WITH THIS CLINICAL INVESTIGATION, AS THE DATA WAS REPORTED IN A REGISTER REPORT FROM EPRD (ENDOPROTHESENREGISTER DEUTSCHLAND) THAT THERE WERE FOUR REVISION SURGERIES PERFORMED TO REPLACE THE INSERT IMPLANT AND THE FEMORAL COMPONENT DUE TO UNSPECIFIED REASONS. THERE IS NO ADDITIONAL INFORMATION ABOUT THE HOSPITAL, PATIENT, AND SURGERY DATA. THE EPRD PROVIDED THIS INFORMATION AS PART OF A CUMULATIVE STATISTICAL STUDY REGARDING FAILURE FREQUENCY. PER CASE DETAILS, NO FURTHER INFORMATION IS AVAILABLE. THEREFORE, BASED ON INSUFFICIENT INFORMATION, FURTHER CLINICAL ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. THE CURRENT CONDITION OF EACH PATIENT IS UNKNOWN AND THE PATIENT IMPACT BEYOND THE REPORTED EVENTS COULD NOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE BUT NOT LIMITED TO PROCEDURAL/USER ERROR, SURGICAL COMPLICATION OR PATIENT MEDICAL HISTORY. 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. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED IN A REGISTER REPORT FROM (B)(6) THAT THERE WERE FOUR REVISION SURGERIES PERFORMED TO REPLACE THE INSERT IMPLANT GENESIS II DISHED AND THE GENESIS II LDK COCR FEMORAL COMPONENT DUE TO UNSPECIFIED REASONS. THERE IS NO ADDITIONAL INFORMATION ABOUT THE HOSPITAL, PATIENT, AND SURGERY DATA. THE EPRD PROVIDED THIS INFORMATION AS PART OF A CUMULATIVE STATISTICAL STUDY REGARDING FAILURE FREQUENCY. THIS REPORT STATES THAT THERE HAVE BEEN 17 REVISION SURGERIES, HOWEVER WE RECEIVED ON 17-FEB-2021 A PREVIOUS REPORT WITH 13 REVISION SURGERIES WHICH WERE COVERED UNDER (B)(4) FDA REPORT NUMBER: 1020279-2021-02103 / BFARM REFERENCE: (B)(4). BASED ON THIS INFORMATION, WE REPORT THE REMAINING 4 REVISION SURGERIES IN THE PRESENT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965582 UNKN GENESIS II TOTAL KNEE FEM COMP COCR CEM PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention