BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 5706188 · Received June 8, 2016

    Report

    Report Number
    1818910-2016-20780
    Event Type
    Injury
    Date Received
    June 8, 2016
    Date of Event
    May 17, 2016
    Report Date
    May 17, 2016
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PK081163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE RECEIVED DEVICES WERE FORWARDED TO COMMERCIALIZED PRODUCT DEVELOPMENT FOR EVALUATION. WITH THE INFORMATION PROVIDED, THE ACTUAL ROOT CAUSE OF LOOSENING AT THE CEMENT/IMPLANT INTERFACE OF THE TIBIAL TRAY CANNOT BE DEFINITIVELY IDENTIFIED. (B)(4) HAS BEEN UNDERTAKEN TO INVESTIGATE FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    UPDATE REC'D 06/15/2016 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS EXPERIENCING PAIN AND SWELLING IN THEIR KNEE. AT THIS TIME THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 07/06/2016.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS TIBIAL COMPONENT LOOSENING. DEPUY CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361575 SMARTSET GMV 40G US EO CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 3444955

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention