BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY/CMW 2G

    MDR report key: 9526719 · Received December 27, 2019

    Report

    Report Number
    1818910-2019-124817
    Event Type
    Injury
    Date Received
    December 27, 2019
    Report Date
    December 9, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295174271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. H10 ADDITIONAL NARRATIVE: ADDED: H6 (PATIENT). H6 PATIENT CODE: NO CODE AVAILABLE (3191) WAS USED TO CAPTURE JOINT INSTABILITY.

    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

    RECORDS REPORT PATIENT RECEIVED AN ATTUNE RIGHT TOTAL KNEE REPLACEMENT DURING A REVISION OF AN UNKNOWN MANUFACTURER'S PARTIAL KNEE ARTHROPLASTY, FOR REASON OF PAIN CAUSED BY NATURAL PROGRESSION OF ARTHRITIS. SINCE RECEIVING HIS ATTUNE TOTAL KNEE REPLACEMENT, THE PATIENT REPORTS OF INCREASING PAIN IN THE PROXIMAL MEDIAL TIBIA AREA OF HIS KNEE, AND A FEELING OF INSTABILITY. CURRENTLY, RECORDS GIVE NO EVIDENCE OF A REVISION SURGERY OF THE ATTUNE TOTAL KNEE, NOR DO THEY PROVIDE PRODUCT OR LOT CODE INFORMATION FOR THE ATTUNE PRODUCTS. THE CEMENT MANUFACTURER IS ALSO CURRENTLY UNKNOWN. DOI: (B)(6) 2016; DOR: UNKNOWN; (RIGHT KNEE) P830055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318593 DEPUY/CMW 2G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 5450-32-500 8205478 10603295174271

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention ATTUNE MEDIAL ANAT PAT 38MM.