BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 11755643 · Received April 30, 2021

    Report

    Report Number
    1818910-2021-09340
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    September 3, 2020
    Report Date
    April 22, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED PREVIOUSLY ON LEGACY COMPLAINT (B)(4) DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. NO IMAGES DEPICT THIS SPECIFIC PRODUCT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT A DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED PREVIOUSLY ON LEGACY COMPLAINT COM-193607 DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. DEVICE HISTORY REVIEW A DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED PREVIOUSLY ON LEGACY COMPLAINT (B)(4). DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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

    PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS INSTABILITY AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE RESECTION OF EXTENSIVE SCAR TISSUE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015 DOR: (B)(6) 2020 LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648219 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3122-040 7997129 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM LT SZ 4 CEM| ATTUNE PS RP INSRT SZ 4 7MM| ATTUNE RP TIB BASE SZ 4 CEM| SMARTSET MV 40G - EO| SMARTSET MV 40G - EO| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM LT SZ 4 CEM| ATTUNE PS RP INSRT SZ 4 7MM| ATTUNE RP TIB BASE SZ 4 CEM| SMARTSET MV 40G - EO| SMARTSET MV 40G - EO