BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 8771141 · Received July 9, 2019

    Report

    Report Number
    1818910-2019-97802
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    July 18, 2017
    Report Date
    July 18, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    UDI-DI
    10603295168379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: CORRECTED:H6(DEVICE CODES) PRODUCT COMPLAINT # ==> PC-(B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT ==> 7997129. DEVICE HISTORY BATCH ==> NULL. DEVICE HISTORY REVIEW ==> A PREVIOUS DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED ON LEGACY COMPLAINT COM-193607 DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. 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). INITIAL REPORTER OCCUPATION: LAWYER. (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

    THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2015. DOR: JUL 18, 2017. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565524 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 3122-040 7997129 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention ATTUNE MEDIAL DOME PAT 32MM| ATTUNE PS FB INSRT SZ 4 8MM| ATTUNE PS FEM RT SZ 4 NAR CEM| ATTUNE MEDIAL DOME PAT 32MM| ATTUNE PS FB INSRT SZ 4 8MM| ATTUNE PS FEM RT SZ 4 NAR CEM