BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY/CMW 2G

    MDR report key: 10535282 · Received September 15, 2020

    Report

    Report Number
    1818910-2020-20062
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    September 5, 2018
    Report Date
    September 1, 2020
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295174271
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). (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

    UPDATE: MEDICAL RECORDS RECEIVED ON AD 21 AUG 2020 WERE REVIEWED ON AD 01 SEP 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TO TREAT PAIN SECONDARY TO END-STAGE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 3 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED SYNOVITIS AND ARTHROFIBROSIS. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A COMPETITOR CONSTRUCT UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2018. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997804 DEPUY/CMW 2G BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-32-500 7797664 10603295174271

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ATTUNE FB TIB BASE SZ 7 CEM.| ATTUNE MEDIAL DOME PAT 41MM.| ATTUNE PS FB INSRT SZ 8 5MM.| ATTUNE PS FEM RT SZ 8 CEM.| DEPUY/CMW 2G.| DEPUY/CMW 2G.| DEPUY/CMW 2G.| ATTUNE FB TIB BASE SZ 7 CEM| ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FB INSRT SZ 8 5MM| ATTUNE PS FEM RT SZ 8 CEM| DEPUY/CMW 2G| DEPUY/CMW 2G| DEPUY/CMW 2G