BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY TIBIA BASE NP RT SZ 7

    MDR report key: 8643600 · Received May 27, 2019

    Report

    Report Number
    1020279-2019-02080
    Event Type
    Injury
    Date Received
    May 27, 2019
    Date of Event
    May 31, 2018
    Report Date
    October 23, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010554390
    PMA / PMN Number
    K042515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, THERE WERE NO X-RAYS OR INTRAOPERATIVE RECORDS PROVIDED. THE ROOT CAUSE OF THE LIMITED RANGE OF MOTION IS UNKNOWN OTHER THAN THE POSSIBILITY OF INABILITY OF THE PATIENT TO PARTICIPATE IN PHYSICAL THERAPY OR REHAB POST OP. PRIOR NUMEROUS RIGHT KNEE SURGERIES COULD HAVE ALSO CONTRIBUTED AS WELL. THE PATIENT IMPACT BEYOND TWO MUA PROCEDURES AND PAIN IS INCONCLUSIVE. IT WAS NOTED THAT THIS ISSUE WAS RESOLVED ON 6/19/18. NO FURTHER CLINICAL ASSESSMENT IS NEEDED AT THIS TIME. 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 AFTER KNEE REPLACEMENT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO LIMITED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437329 JOURNEY TIBIA BASE NP RT SZ 7 PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. 17FM01981 03596010554390

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R