BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 5 CEM

    MDR report key: 8713702 · Received June 19, 2019

    Report

    Report Number
    1818910-2019-96321
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    June 28, 2017
    Report Date
    May 31, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042396
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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: PRODUCT CODE 150600005, WORK ORDER (B)(4) WAS MANUFACTURED ON 20-JUN-2013. 12 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS NO SCRAP PARTS ASSOCIATED WITH THIS LOT. THERE WAS 1 NON-CONFORMANCE, NC-031987 ASSOCIATED WITH THIS LOT. ON REVIEW OF THIS NC IT IS RELATED TO A POLY PLUG PRESENT IN THE UNDERCUT SECTION OF AN ATTUNE FB TRAY. THERE IS NO CORRELATION WITH THIS NON-CONFORMANCE AND THE FAILURE MODE OF THIS PC.

    Additional Manufacturer Narrative · 1

    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. 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

    MEDICAL RECORDS RECEIVED 23 JUL 2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PATIENT UNDERWENT A LEFT TKA AND WAS LATER REVISED FOR PAIN AND RECURRENT EFFUSIONS. INTRAOPERATIVE FINDINGS WERE ASEPTIC LOOSENING OF THE TIBIAL TRAY AT THE IMPLANT-CEMENT INTERFACE. OSTEOLYSIS WAS ALSO FOUND ALONG THE PROXIMAL TIBIA. DOI: (B)(6) 2014; DOR: (B)(6) 2017, (TRAY AND INSERT ONLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506639 ATTUNE FB TIB BASE SZ 5 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 1506-00-005 4380129 10603295042396

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention