BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 9209790 · Received October 18, 2019

    Report

    Report Number
    1818910-2019-110743
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 26, 2019
    Report Date
    September 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K08115
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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, 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. K08115.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE IMPLANT TO CEMENT INTERFACE. DEPUY CEMENT MANUFACTURER WAS USED. NO CEMENT ADHERED TO TRAY, ALL CEMENT WAS STUCK TO BONE ONLY. DO NOT HAVE LOT NUMBER FOR CEMENT. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003580 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention PFC SIGMARP STB TB IN 3 17.5