BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE KNEE PATELLA

    MDR report key: 14977359 · Received July 11, 2022

    Report

    Report Number
    1818910-2022-12711
    Event Type
    Injury
    Date Received
    July 11, 2022
    Date of Event
    April 19, 2022
    Report Date
    July 11, 2022
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT - A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    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 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE ON (B)(6) 2022 SECONDARY TO PAIN, INABILITY TO BEAR WEIGHT, AND LOCKING OF THE KNEE. INTRAOPERATIVE FINDINGS WERE OSTEOPENIC BONE, INCREASED LAXITY IN FLEXION, TIBIAL TRAY SUBSIDENCE WITH OVERGROWTH OF OSTEOPHYTE FORMATION, AN OSTEOPHYTE FROM THE QUADRICEPS TENDON JUST PROXIMAL TO THE PATELLA, AND TRAY LOOSENING AT THE IMPLANT TO CEMENT INTERFACE. PART/LOT WAS NOT PROVIDED OF THE IMPLANTS, THOUGH SURGEON STATES THEY ARE OF THE ATTUNE KNEE SYSTEM AND PATHOLOGY REPORT STATES ONE OF THE IMPLANTS WAS MARKED WITH THE CHARACTERS "6150233 AND SZ5" DOI: (B)(6) 2015; DOR: (B)(6) 2022 (RIGHT KNEE).

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT HAD A FAILED RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS SIGNIFICANT PAIN, SWELLING, INSTABILITY, WITH MECHANICAL SYMPTOMS, LOCKING OF THE RIGHT KNEE. PRIOR TO SURGERY A CT SCAN WAS REPORTED TO SHOW EFFUSION. THE TIBIAL TRAY WAS NOTED TO HAVE SUBSIDENCE WITH OVERGROWTH OF BONY RIM. TIBIAL TRAY WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE. ALL COMPONENTS WERE REVISED. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058502 UNK ATTUNE KNEE PATELLA KNEE PATELLA JWH DEPUY IRELAND 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention UNK ATTUNE KNEE PATELLA.| UNK ATTUNE KNEE TIBIAL INSERT.| UNK ATTUNE KNEE TIBIAL TRAY.| UNKNOWN KNEE FEMORAL.