BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY CMW 2 20G

    MDR report key: 11447912 · Received March 9, 2021

    Report

    Report Number
    1818910-2021-04795
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    March 26, 2020
    Report Date
    February 26, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168621
    PMA / PMN Number
    P960001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: DEVICE HISTORY REVIEWED: 9023930. 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. (B)(4) UNITS RELEASED. LOT EXPIRY DATE: 31 DECEMBER 2021.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, INFECTION, ARTHROFIBROSIS, SYNOVITIS, AND ADHESIONS. THE SURGEON NOTED SOME TIBIAL AND FEMORAL BONE LOSS. ALL COMPONENTS WERE REMOVED. THE PATIENT WAS REVISED WITH A COMPETITOR ANTIBIOTIC SPACER. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2019, DOR: (B)(6) 2020 RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344455 DEPUY CMW 2 20G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3322-020 9023930 10603295168621

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ATTUNE CR FEM RT SZ 6 CEM.| ATTUNE CR RP INSRT SZ 6 5MM.| ATTUNE MEDIAL ANAT PAT 41MM.| ATTUNE RP TIB BASE SZ 7 CEM.| DEPUY CMW 2 20G.| DEPUY CMW 2 20G.