BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 4 CEM

    MDR report key: 9135740 · Received September 30, 2019

    Report

    Report Number
    1818910-2019-106807
    Event Type
    Injury
    Date Received
    September 30, 2019
    Date of Event
    October 17, 2018
    Report Date
    September 9, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295492061
    PMA / PMN Number
    K170806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 : 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. 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). 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

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE REPLACEMENT, IT DID NOT HEAL AND WAS WONDERING IF SHE IS ALLERGIC TO METAL. SHE WAS TRYING TO GET WHAT KIND OF METAL CONTENT IS IN THE TOTAL KNEE REPLACEMENT TO TEST IF SHE IS ALLERGIC TO IT. DOI: (B)(6) 2018 - DOR: NOT REVISED (UNK KNEE) ATTUNE MEDIALIZE DOME 8750415. FEMORAL CRUCIATE RETAINING NARROW 5X6 IN RIGHT 8U2507. ATTUNE KNEE SYSTEM TIBIAL BASE FIXED BEARING 8863071. ATTUNE TIBIAL INSERT FIX BEARING CRUCIATE RETAINING HF6417.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927787 ATTUNE FB TIB BASE SZ 4 CEM KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 8863071 10603295492061

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention ATTUNE CR FB INSRT SZ 6 6MM| ATTUNE MEDIAL DOME PAT 41MM