BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCK COMP PL 10H 193MM

    MDR report key: 7962899 · Received October 12, 2018

    Report

    Report Number
    1020279-2018-02126
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    March 3, 2018
    Report Date
    December 18, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    03596010523280
    PMA / PMN Number
    K033669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED. PER THE PHOTO PROVIDED, THE IMPLANT DID FRACTURE INTO TWO PIECES. A CLINICAL EVALUATION WAS CONDUCTED AND NO CLINICALLY RELEVANT DOCUMENTATION WAS PROVIDED, THEREFORE A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. SHOULD RELEVANT DOCUMENTATION BECOME AVAILABLE, THE MEDICAL ASSESSMENT TASK MAY BE RE-EVALUATED. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCH 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 AFTER A PLATE IMPLANTATION, WHEN THE PATIENT WAS EXERCISING AT HOME, HE SUDDENLY HAD A TEAR IN HIS RIGHT THIGH WITH PAIN AND LIMITED MOBILITY. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AND REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803358 4.5MM LCK COMP PL 10H 193MM PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 13AT26957 03596010523280

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R