BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 9979043 · Received April 20, 2020

    Report

    Report Number
    1818910-2020-11011
    Event Type
    Injury
    Date Received
    April 20, 2020
    Date of Event
    August 9, 2019
    Report Date
    April 8, 2020
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 =A PREVIOUS DHR REVIEW ((B)(4)) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (7122502). 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). 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 BILATERAL PRIMARY ATTUNE SYSTEM TO TREAT END-STAGE SEVERE ARTHRITIS WITH DEFORMITY. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED ON EACH KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT REVISION TO TREAT ASEPTIC LOOSENING. UPON ENTERING THE KNEE, THE SURGEON ENCOUNTERED AND EXCISED SYNOVITIS. THE TIBIAL TRAY AND FEMORAL COMPONENTS WERE GROSSLY LOOSE AT AN UNKNOWN INTERFACE AND REVISED. THE SURGEON DISCOVERED SEVERE OSTEOLYSIS ON THE FEMORAL CONDYLE. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2019; RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440890 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3122-040 7122502 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ATTUNE FB TIB BASE SZ 7 CEM| ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FB INSRT SZ 7 8MM| ATTUNE PS FEM RT SZ 7 CEM| SMARTSET MV 40G - EO| SMARTSET MV 40G - EO