BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII C/R ART INS SZ 7-8 9MM

    MDR report key: 8349876 · Received February 19, 2019

    Report

    Report Number
    1020279-2019-00683
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    October 25, 2016
    Report Date
    June 16, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010207999
    PMA / PMN Number
    K951987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. C-0232077, C-0232614, C-0232615, C-0232616: A CLINICAL EVALUATION WAS CONDUCTED AND THE RESULTS FROM THE ARTHROCENTESIS REVEALED A CRP LEVEL OF 10.00MG/L ALL OTHER LABS WHERE WITHIN NORMAL LIMITS. THERE WAS NO INDICATION OF ANY MEDICAL INTERVENTIONS PROVIDED TO ADDRESS THE ELEVATED CRP. THE X-RAYS PROVIDED TAKEN YEARS AFTER THE ELEVATED CRP PROVIDED HAD THE SUSPICION OF THE LOOSENING OF THE TIBIAL OR FEMORAL COMPONENTS OF RIGHT TKA. DETAILS REGARDING THE PATIENT¿S WEIGHT-BEARING STATUS, BONE QUALITY, FALL/TRAUMA HISTORY, AND OTHER ADDITIONAL CLINICAL RELEVANT INFORMATION HAVE NOT BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE DEVICE FOR EVALUATION THE ROOT CAUSE OF THE REPORTED PAIN CANNOT BE DETERMINED. HOWEVER, THE LOOSENING OF THE COMPONENTS COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORTED THE PAIN. ALTHOUGH A FLUOROSCOPICALLY GUIDED RIGHT TKA ASPIRATION WAS PERFORMED TWO MONTHS POST REVISION NO RESULT WERE PROVIDED FOR REVIEW. THEREFORE, WERE ARE UNABLE TO CONFIRM AN INFECTION AS A CONTRIBUTORY FACTOR. THE PATIENT IMPACT BEYOND THE REPORTED PAIN CANNOT BE DETERMINED. NO FURTHER CLINICAL 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 PATIENT HAD AN ARTHROCENTESIS OF RIGHT KNEE DUE TO CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144266 GII C/R ART INS SZ 7-8 9MM PRSTHSIS,KNEE,PTELLFMROTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/POLYMER JWH SMITH & NEPHEW, INC. 14BM03879 03596010207999

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R