BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 7823999 · Received August 28, 2018

    Report

    Report Number
    1818910-2018-67951
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    June 30, 2016
    Report Date
    August 14, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CONCOMITANT MEDICAL PRODUCTS: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 12MM; ATTUNE PS FEM LT SZ 5 NAR CEM; SMARTSET MV 40G - EO. INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL ¿ ATTORNEY.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS A TORN EXTENSOR MECHANISM AND COMPROMISED MCL. TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE WAS ALSO REPORTED. THE CEMENT MANUFACTURER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662982 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 7797726 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention