BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS FEM LT SZ 6 CEM

    MDR report key: 12384547 · Received August 30, 2021

    Report

    Report Number
    1818910-2021-18883
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    August 10, 2021
    Report Date
    August 10, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    MBH
    UDI-DI
    10603295041634
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : PRODUCT CODE 150410106 WORK ORDER (B)(4) WAS MANUFACTURED ON 03-SEPTEMBER-2019. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. NO SCRAP ASSOCIATED WITH THIS LOT. NO REPROCESSING ASSOCIATED WITH THIS LOT. 4 NONCONFORMANCES ASSOCIATED WITH THIS LOT. NR-0134265 RELATES TO A THERMOCOUPLE CALIBRATION FAILURE ON SEAL006. NR-0134328 RELATES TO A PHOTOHELIC GAUGE CALIBRATION FAILURE. NR-0139348 RELATES TO INCORRECT OPERATING PARAMETERS IN THE DRAG BOWL PROCESS IN THE FEMORAL VALUE STREAM AND HAD A ¿USE AS IS¿ PRODUCT DISPOSITION. NR-0142098 WAS OPENED AS THERE WAS NO DEFINED INSPECTION METHOD FOR CTQ27 ON ATTUNE PS PRODUCT. NONE OF THE ABOVE NONCONFORMANCES HAVE A CORRELATION TO THE COMPLAINT FAILURE MODE.

    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.

    Description of Event or Problem · 1

    IT WAS STATED THAT PATIENT WAS REVISED DUE TO INFECTED KNEE. SURGEON EXPLANTED COMPONENTS REVISING WITH ARTICULATING SPACER. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279599 ATTUNE PS FEM LT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL MBH DEPUY IRELAND - 9616671 1504-10-106 9263037 10603295041634

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention ATTUNE CEMENTED STEM 14X50MM| ATTUNE MEDIAL DOME PAT 35MM| ATTUNE PS FB INSRT SZ 6 6MM| ATTUNE PS FEM LT SZ 6 CEM| ATUNE CRS FB TIB BASE SZ 6 CEM| ATTUNE CEMENTED STEM 14X50MM| ATTUNE MEDIAL DOME PAT 35MM| ATTUNE PS FB INSRT SZ 6 6MM| ATTUNE PS FEM LT SZ 6 CEM| ATUNE CRS FB TIB BASE SZ 6 CEM