BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS FEM RT SZ 3 NAR CEM

    MDR report key: 9210054 · Received October 18, 2019

    Report

    Report Number
    1818910-2019-110766
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    December 21, 2015
    Report Date
    September 27, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295041825
    PMA / PMN Number
    K111433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS IS A DUPLICATE OF 1818910-2019-90014. 1818910-2019-110766 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-90014 WILL BE KEPT FOR INVESTIGATIONAL PURPOSES.

    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

    MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 27 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY AND A REVISION OF THE LEFT UNI-COMPARTMENTAL ARTHROPLASTY. THIS PC PERTAINS TO THE RIGHT KNEE. THE SURGEON UTILIZED DEPUY COMPONENTS AND TWO DEPUY CEMENTS. NO COMPLICATIONS WERE NOTED IN THE SURGICAL NOTES. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION OF THE ATTUNE POSTERIOR STABILIZED ROTATING PLATFORM TO A SIGMA TC3 ROTATING PLATFORM COMPONENT WITH METAPHYSEAL SLEEVES TO ADDRESS AN UNSTABLE RIGHT KNEE. THE SURGEON REPORTED THAT TIBIAL COMPONENT HAD SUBLUXED POSTERIORLY DISENGAGING THE POSTERIOR POST. THE SURGEON NOTED THAT THE ROTATIONAL INSTABILITY WAS OF UNKNOWN ETIOLOGY AND DECIDED TO REMOVE BOTH THE FEMUR AND TIBIAL COMPONENTS. THERE WAS A CRACK NOTED IN THE MEDIAL CONDYLE OF THE FEMUR, WHICH WAS ¿FIXED¿ WITH 7.3 CANCELLOUS SCREW. DEPUY COMPONENTS WERE PLACED ALONG WITH 2 SMARTSET CEMENTS DURING THE REVISION. DOI: (B)(6) 2015; DOR: (B)(6) 2015; (RT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001028 ATTUNE PS FEM RT SZ 3 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 515102 10603295041825

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention