BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 7756296 · Received August 7, 2018

    Report

    Report Number
    1818910-2018-65866
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    January 27, 2016
    Report Date
    July 11, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). 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

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. MEDICAL DEVICES: ATTUNE PS FEM LT SZ 4 CEM 150410104 LOT: 441606, ATTUNE PS FB INSRT SZ 4 12MM 151640412 LOT: 323631.

    Description of Event or Problem · 1

    RECEIVED MEDICAL RECORDS ON (B)(6) 2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PATIENT RECEIVED BILATERAL ATTUNE TOTAL KNEE REPLACEMENTS ON (B)(6) 2014. THIS COMPLAINT ADDRESSES THE LEFT KNEE. LEFT TOTAL KNEE REVISED TO ADDRESS ASEPTIC LOOSENING OF TIBIA AND VILLONODULAR SYNOVITIS. REVISING SURGEON EXCISED A LARGE AMOUNT OF NON-INFLAMMATORY VILLONODULAR SYNOVITIS, AND IDENTIFIED THAT THE TIBIAL COMPONENT WAS LOOSE, BUT DID NOT SPECIFY AT WHAT INTERFACE(S). TIBIAL BASE PLATE, TIBIAL INSERT, AND FEMUR COMPONENTS WERE REVISED. DEPUY CEMENT WAS UTILIZED IN THE PRIMARY BILATERAL SURGERIES. DOI: (B)(6) 2014; DOR: (B)(6) 2016; (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600994 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3620327 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention