BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN II CEMENTED TIBIAL B/PLATE SZ 2 LEFT

    MDR report key: 8547007 · Received April 24, 2019

    Report

    Report Number
    1020279-2019-01651
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    July 18, 2017
    Report Date
    October 21, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010206244
    PMA / PMN Number
    K951987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, BASED ON THE DOCUMENTATION PROVIDED, THE ROOT CAUSE OF THE TIBIAL COMPONENT LOOSENING, ¿SUBSIDENCE¿ AND SUBSEQUENT REVISION WAS MOST LIKELY ¿(HAVING FAILED HER EARLIER CEMENT FIXATION) ¿BECAUSE OF THE BONE INFARCTS¿ (C-241697, C-241698); HOWEVER, INTERVAL RADIOLOGICAL IMAGING WAS NOT PROVIDED FOR EVALUATION. ¿SIGNIFICANT BONE LOSS FROM REMOVAL OF THE FEMORAL COMPONENT¿ OCCURRED DUE TO THE IMPLANT BEING STABLE BUT WAS DEEMED NECESSARY FOR TIBIAL ¿ACCESS¿ AND TO MATCH ROTATION, POSITION, AND ALIGNMENT OF THE EXTREMITY¿ (C-241699). THE PATIENT IMPACT BEYOND THE TIBIAL LOOSENING, REVISION AND SUBSEQUENT FEMORAL BONE LOSS CANNOT BE DETERMINED. A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE CORRESPONDING PRODUCTS DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES. WITHOUT THE ACTUAL DEVICE INVOLVED OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINTS CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT KNEE REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIA COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340408 GEN II CEMENTED TIBIAL B/PLATE SZ 2 LEFT PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. 14KM13247 03596010206244

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R