BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CEMENTED STEM 14X50MM

    MDR report key: 9545631 · Received January 3, 2020

    Report

    Report Number
    1818910-2020-00309
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    November 24, 2018
    Report Date
    December 10, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295475163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT - NULL. DEVICE HISTORY BATCH - NULL. DEVICE HISTORY REVIEW - NULL. 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). 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

    ON (B)(6) 2017: THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. ATTUNE IMPLANTS WERE UTILIZED WITH DEPUY CEMENT X2. PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2018: THE PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE FOR PAIN, MILD EFFUSION, AND RADIOGRAPHIC DETECTION OF INCREASED BONE UPTAKE IN FEMUR AND TIBIA. INTRAOPERATIVELY, THE TIBIA TRAY WAS FOUND INTERNALLY ROTATED AND SURGEON NOTES IMPLIES TIBIAL TRAY LOOSE AT IMPLANT-CEMENT INTERFACE AS THE COMPONENT DISENGAGED FROM CEMENT MANTLE WITH ONE ATTEMPT WHILE LEAVING CEMENT MANTLE ADHERED TO TIBIA. NO INFECTION. PATELLA WAS NOT REVISED. ONLY THE TIBIA TRAY AND POLY INSERT WERE REPLACED. THIS IS CAPTURED ON (B)(4). ON (B)(6) 2018: PATIENT DIAGNOSED WITH RIGHT KNEE WOUND DEHISCENCE WITH SUPERFICIAL INFECTION. PATIENT RECEIVED IRRIGATION AND DEBRIDEMENT DUE TO INFECTION. INTRAOPERATIVELY, SURGEON FOUND ARTHROTOMY COMPLETELY INTACT AND NOT ABLE TO EXPRESS FLUID FROM ARTHROTOMY ITSELF. NO IMPLANTS REMOVED AT THIS PROCEDURE. ON (B)(6) 2018: PATIENT DIAGNOSED WITH INFECTED RIGHT KNEE ARTHROPLASTY AND RECEIVES RESECTION OF RIGHT KNEE ARTHROPLASTY WITH PLACEMENT OF DYNAMIC SPACER. PATIENT RECEIVED A COMPLETE SYNOVECTOMY AND ALL COMPONENTS (TIBIA, FEMORAL, PATELLA, INSERT) WERE REMOVED. SURGEON THEN IMPLANTED SIZE 4 SIGMA FEMORAL COMPONENT AND ANTIBIOTIC SPACER BOTH CEMENTED IN PLACE (CEMENT MANUFACTURER NOT IDENTIFIED). ON (B)(6) 2019: PATIENT RECEIVES A TOTAL REVISION KNEE ARTHROPLASTY. FEMORAL COMPONENT (IMPLANTED (B)(6) 2018) AND ANTIBIOTIC SPACER (IMPLANTED (B)(6) 2018) BOTH REMOVED AND REPLACED WITH NON-DEPUY REVISION KNEE SYSTEM WITH UNIDENTIFIED MANUFACTURER CEMENT. DOI: (B)(6) 2017. DOR: (B)(6) 2018 (TIBIAL TRAY AND INSERT). DOE: (B)(6) 2018 (IRRIGATION AND DEBRIDEMENT). DOR: (B)(6) 2018 (REVISION TIBIAL TRAY, REVISION INSERT, FEMORAL, PATELLA). DOR: (B)(6) 2019 (SIGMA FEMORAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8098 ATTUNE CEMENTED STEM 14X50MM ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE STEMS JWH DEPUY IRELAND - 9616671 1512-14-050 HP1266 10603295475163

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention