BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II LONG STEM 10MMX70MM

    MDR report key: 7927720 · Received October 2, 2018

    Report

    Report Number
    1020279-2018-01991
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    September 29, 2016
    Report Date
    May 7, 2019
    Manufacturer
    SMITH AND NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556045497
    PMA / PMN Number
    K953274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WERE NOT RETURNED. A CLINICAL EVALUATION WAS CONDUCTED AND BASED ON THE INFORMATION PROVIDED THE ROOT CAUSE OF THE POOR RANGE MOTION CAPTURED IN C-212242, C-212279, C-212283, C-212304, C-212306), MULTIPLE FALL HISTORY CAPTURED IN (C-226008), AND THE LEFT KNEE ARTHROFIBROSIS CAPTURED IN C-212242, C-212279, C-212283, C-212304, C-212306, COULD NOT DEFINITIVELY BE DETERMINED. HOWEVER, THE REPORTED NON-COMPLIANCE, CHRONIC OPIOID USAGE, MORBID OBESITY(WEIGHING 260.7 POUNDS), AND FALL HISTORY CANNOT BE RULED OUT AS CONTRIBUTORY FACTORS TO THE REPORTED ISSUES. THE FUTURE IMPACT TO THE PATIENT CANNOT BE DETERMINED. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES WITH THE SAME FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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 ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE POOR RANGE OF MOTION AND EXPERIENCING MORE PAIN THAN EXPECTED. AN ASPIRATION WAS PERFORMED TO RULE OUT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767572 GENESIS II LONG STEM 10MMX70MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH AND NEPHEW, INC. 16FM06574 00885556045497

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization