BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS RP INSRT SZ 7 14MM

    MDR report key: 9430339 · Received December 6, 2019

    Report

    Report Number
    1818910-2019-121668
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    November 5, 2019
    Report Date
    November 14, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295052760
    PMA / PMN Number
    K111433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 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: 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS, RIGHT TKA, SO MANIPULATION UNDER ANESTHESIA: ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE). DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 150410107. LOT: 8144922. DESCRIPTION: ATTUNE POST/STAB FEM LT SZ 7 CEMENTED. CATALOG ID: 151810032. LOT: 9102726. DESCRIPTION: ATTUNE MEDIAL ANAT PAT 32MM. CATALOG ID: 150680008. LOT: 9168128. DESCRIPTION: ATTUNE ROTATING PLATFORM TIBIAL BASE SIZE 8 CEMENTED. CATALOG ID: 151650710. LOT: 9099637. DESCRIPTION: ATTUNE PS/RP INSERT SZ 7 10MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218361 ATTUNE PS RP INSRT SZ 7 14MM ATTUNE IMPLANT : KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671 8144922 10603295052760

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention