BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT POR KEEL TIB TRAY SZ5

    MDR report key: 7826148 · Received August 29, 2018

    Report

    Report Number
    1818910-2018-67979
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 1, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    NJL
    UDI-DI
    10603295025894
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: MBT POR KEEL TIB TRAY SZ5; LCS COMPLETE M/B PAT POR LG; LCS COMPLETE FEM POR L LG; LCS COMP RP INSERT LG 12.5MM; UNKNOWN BONE CEMENT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AT THE BONE TO IMPLANT INTERFACE. LCS PRESSFIT FEMUR, TIBIA, POLY AND PATELLA WERE REMOVED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669658 MBT POR KEEL TIB TRAY SZ5 MBT TIBIAL TRAY : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS, INC. 1818910 8783840 10603295025894

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention