BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 4 CEM

    MDR report key: 11671964 · Received April 15, 2021

    Report

    Report Number
    1818910-2021-08023
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    December 18, 2018
    Report Date
    March 31, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042587
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED BY THE MANUFACTURING SITE. PRODUCT CODE: 150610004, WORK ORDER: (B)(4) WAS MANUFACTURED ON 08- JUN -2014. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS NO SCRAP ASSOCIATED WITH THIS LOT. THERE WAS ONE REPROCESSING ASSOCIATED WITH THIS LOT: MRR NO. 1306838 - 20 PART WAS REPROCESSED FOR FIT FOR USE (NC: 041585). THERE IS NO CORRELATION WITH THIS REPROCESSING AND THE FAILURE MODE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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

    PATIENT RECEIVED PRIMARY ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON NOTES THE SURGERY WAS COMPLEX DUE TO THE PATIENT¿S MORBID OBESITY WITH A BMI OVER 40. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, DISCOMFORT, WALKING DIFFICULTY, STIFFNESS, REDUCED ROM AND FLEXION CONTRACTURE. UPON ENTERING THE JOINT, MODERATE EFFUSION WAS EVACUATED AND SYNOVITIS DEBRIDED. THE FEMORAL COMPONENT WAS MALPOSITIONED IN SLIGHT FLEXION AND REVISED WITH MINIMAL BONE LOSS. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WERE TWO LARGE TIBIAL CYSTIC REGIONS DEBRIDED. THERE WAS BACKSIDE WEAR ON THE REVISED TIBIAL INSERT. PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH A COMPETITOR REVISION KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2018, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572563 ATTUNE RP TIB BASE SZ 4 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-10-004 7920045 10603295042587

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention ATTUNE MEDIAL DOME PAT 35MM.| ATTUNE PS FEM LT SZ 5 NAR CEM.| ATTUNE PS RP INSRT SZ 5 10MM.| ATTUNE RP TIB BASE SZ 4 CEM.| DEPUY CMW 1 40G.| DEPUY CMW 1 40G.| ATTUNE MEDIAL DOME PAT 35MM| ATTUNE PS FEM LT SZ 5 NAR CEM| ATTUNE PS RP INSRT SZ 5 10MM| ATTUNE RP TIB BASE SZ 4 CEM| DEPUY CMW 1 40G| DEPUY CMW 1 40G