BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 13824703 · Received March 19, 2022

    Report

    Report Number
    1818910-2022-04943
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    August 11, 2021
    Report Date
    March 18, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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.

    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 PREVIOUS DHR (DEVICE HISTORY RECORD) REVIEW ((B)(4)) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (7915796).

    Description of Event or Problem · 0

    PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT SEVERE END-STAGE ARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN, SWELLING, AND INSTABILITY SECONDARY TO LOOSENING AND SUBSIDENCE OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED PERICAPSULAR SCAR TISSUE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT AND PATELLA WERE RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED AN ATTUNE REVISION CONSTRUCT SECURED WITH COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR (B)(6) 2021, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007710 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3122-040 7915796 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention ATTUNE MEDIAL ANAT PAT 32MM| ATTUNE PS FEM RT SZ 6 NAR CEM| ATTUNE PS RP INSRT SZ 6 7MM| ATTUNE RP TIB BASE SZ 4 CEM| SMARTSET GMV 40G US EO