BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT STEP WEDGE SZ4 5MM

    MDR report key: 8623645 · Received May 20, 2019

    Report

    Report Number
    1818910-2019-94000
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    April 30, 2019
    Report Date
    April 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    NJL
    UDI-DI
    10603295026747
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    SURGEON HAD TO REVISE AN SIGMA TC3 AND MBT REVISION TIBIA DUE TO PATIENT DISCOMFORT AND INSTABILITY. SURGEON REMOVED ALL EXISTING IMPLANTS AND PERFORMED REVISION WITHOUT ANY INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418715 MBT STEP WEDGE SZ4 5MM MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY NJL DEPUY ORTHOPAEDICS, INC. 1818910 NA 10603295026747

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention