BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR FEM RT SZ 4 CEM

    MDR report key: 9273346 · Received November 4, 2019

    Report

    Report Number
    1818910-2019-113863
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    May 16, 2016
    Report Date
    October 9, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295041191
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). MFR# 1818910-2019-113863 IS BEING RETRACTED SINCE IT WAS FOUND TO BE A DUPLICATE OF MFR# 1818910-2016-20350. MFR# 1818910-2016-20350 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). 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 AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, DISCOMFORT, AND DIFFICULTY WALKING. THE SURGEON NOTED ALL COMPONENTS WERE WELL-FIXED. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS NOT REVISED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION.. DOI: (B)(6) 2014. DOR: (B)(6) 2016; RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070266 ATTUNE CR FEM RT SZ 4 CEM ATTUNE IMPLANT : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 574840 10603295041191

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention