BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 7 POR

    MDR report key: 7946705 · Received October 9, 2018

    Report

    Report Number
    1818910-2018-71745
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    September 17, 2018
    Report Date
    September 17, 2018
    Manufacturer
    DEPUY IRELAND - 961667
    Product Code
    NJL
    UDI-DI
    10603295416296
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. ADDED: H6 (PATIENT AND DEVICE CODE).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CONCOMITANT MED PRODUCTS: ATTUNE RP TIB BASE SZ 7 POR KNEE TIBIAL TRAY COMPONENT; ATTUNE FEM POR CR RT SZ 6 KNEE FEMUR COMPONENT; ATTUNE CR RP INSRT SZ 6 6MM KNEE TIBIAL INSERT COMPONENT; ATTUNE MEDIAL ANAT PAT 41MM KNEE PATELLA COMPONENT; UNKNOWN BONE CEMENT.

    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. CONCOMITANT MED PRODUCTS: ATTUNE RP TIB BASE SZ 7 POR KNEE TIBIAL TRAY COMPONENT; ATTUNE FEM POR CR RT SZ 6 KNEE FEMUR COMPONENT; ATTUNE CR RP INSRT SZ 6 6MM KNEE TIBIAL INSERT COMPONENT; ATTUNE MEDIAL ANAT PAT 41MM KNEE PATELLA COMPONENT; UNKNOWN BONE CEMENT.

    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. CONCOMITANT MEDICAL PRODUCTS: ATTUNE RP TIB BASE SZ 7 POR KNEE TIBIAL TRAY COMPONENT; ATTUNE FEM POR CR RT SZ 6 KNEE FEMUR COMPONENT; ATTUNE CR RP INSRT SZ 6 6MM KNEE TIBIAL INSERT COMPONENT; ATTUNE MEDIAL ANAT PAT 41MM KNEE PATELLA COMPONENT; UNKNOWN BONE CEMENT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EVALUATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: PRODUCT CODE (B)(4), LOT NUMBER 8564886 DEVICE HISTORY REVIEW: PRODUCT CODE (B)(4), WORK ORDER (B)(4) WAS MANUFACTURED ON 24 JUN 2017.17 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. 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

    PAIN - ONGOING ANTERIOR AND INFERIOR MEDIAL KNEE PAIN AND TENDERNESS. BONE SCAN DOES SHOW QUITE INTENSE UPTAKE UNDER THE TIBIAL TRAY. TIBIAL TRAY REMOVED AND BONE PEELED AWAY FROM TRAY TO INDICATE FIBROUS INGROWTH ONLY. TIBIAL TRAY BEING SENT AWAY FOR EVALUATION. MALE PATIENT (B)(6). DOI: (B)(6) 2018. DOR: (B)(6) 2018. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790940 ATTUNE RP TIB BASE SZ 7 POR ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 961667 8564886 10603295416296

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention