BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 6 CEM

    MDR report key: 11455172 · Received March 10, 2021

    Report

    Report Number
    1818910-2021-04850
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    July 5, 2019
    Report Date
    February 26, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042600
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT 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 : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5 CORRECTED: D4 PRIMARY UDI NUMBER. IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    MEDICAL RECORDS RECEIVED: MEDICAL RECORDS WERE REVIEWED BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. DOI: (B)(6) 2015: 61-YEAR-OLD MALE PATIENT RECEIVED AN ATTUNE LEFT TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PART/LOT AVAILABLE ON (B)(6) OPERATIVE REPORTS AD (B)(6) 2024 (1) PAGE 3. DOR: (B)(6) 2019: 65-YEAR-OLD MALE PATIENT RECEIVED A TOTAL LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON PERFORMED A COMPLETE SYNOVECTOMY. THE TIBIAL TRAY WAS AT AN UNKNOWN INTERFACE WITH MIGRATION INTO VARUS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA AND FEMORAL COMPONENT WERE WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019. LEFT KNEE

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

    PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN AND TIBIAL TRAY MIGRATION, MISPOSITIONING, AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL INSERT AND TIBIAL TRAY WERE REVISED. THE PATELLAR AND FEMORAL COMPONENTS WERE RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND CEMENT X 2. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019 LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351206 ATTUNE RP TIB BASE SZ 6 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-10-006 8074705 10603295042600

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention ATTUNE MEDIAL ANAT PAT 38MM| ATTUNE PS FEM LT SZ 6 CEM| ATTUNE PS RP INSRT SZ 6 8MM| ATTUNE RP TIB BASE SZ 6 CEM| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G| ATTUNE MEDIAL ANAT PAT 38MM| ATTUNE PS FEM LT SZ 6 CEM| ATTUNE PS RP INSRT SZ 6 8MM| ATTUNE RP TIB BASE SZ 6 CEM| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G