BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 7 CEM

    MDR report key: 9235014 · Received October 24, 2019

    Report

    Report Number
    1818910-2019-111878
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    May 2, 2018
    Report Date
    October 2, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS IS A DUPLICATE REPORT OF 1818910-2018-60943. 1818910-2019-111878 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2018-60943 WILL BE KEPT FOR INVESTIGATIONAL PURPOSES.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN AND INSTABILITY. PRE-OPERATIVE EXAM WAS NOTABLE FOR FLEXION GAP LAXITY. THE SURGEON NOTED THE FEMORAL COMPONENT WAS FOUND TO BE SECURE, HOWEVER, IT WAS NOTED TO BE APPROXIMATELY 10 DEGREES INTERNALLY ROTATED RELATIVE TO THE TRANS-EPICONDYLAR AXIS, WHICH AGGRAVATED THE LATERAL SIDE FLEXION GAP. THE FEMORAL COMPONENT AND PATELLA COMPONENT WERE BOTH WELL-FIXED AND NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029118 ATTUNE RP TIB BASE SZ 7 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 8286625 10603295042617

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention