BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR FB INSRT SZ 5 14MM

    MDR report key: 7649826 · Received June 29, 2018

    Report

    Report Number
    1818910-2018-63464
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 6, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295045700
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY = UPDATE 21-JAN-2021: THE INVESTIGATION WAS RE-OPENED UPON RECEIPT OF ADDITIONAL INFORMATION. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. 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. DEVICE HISTORY LOT =DEVICE HISTORY RECORDS REVIEW FOR PRODUCT NO.151620514 LOT NO. 7796606 DESCRIPTION ATTUNE CR FB INSRT SZ 5 14MM. 25 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE NO NCS OR DEVIATIONS ASSOCIATED WITH THIS LOT DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION IT WILL BE REOPENED. COC REVIEW CERTIFICATE OF CONFORMANCE 6960817 REVIEWED FOR PRODUCT CODE 151620600, WORK ORDER (B)(4) AND MET SPECIFICATION.

    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: UDI: (B)(4). ADDED: A2 (BIRTH DATE), D4 (EXPIRATION), H6 (PATIENT). NO CODE AVAILABLE WAS ADDED TO CAPTURE MEDICAL DEVICE REMOVAL.

    Description of Event or Problem · 0

    MEDICAL RECORDS ALLEGES TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE.

    Additional Manufacturer Narrative · 1

    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). INVESTIGATION SUMMARY: NO PRODUCT 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS DISSOCIATED TIBIAL INSERT. DISSOCIATED TIBIAL INSERT TWICE: ONCE AFTER THE PRIMARY AND AGAIN AFTER THE FIRST REVISION/INSERT EXCHANGE. DOI: (B)(6) 2017. DOI: (B)(6) 2018 ( INSERT AND TRAY ) . DOR: (B)(6) 2018. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492843 ATTUNE CR FB INSRT SZ 5 14MM ATTUNE IMPLANT : KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671 1516-20-514 7796606 10603295045700

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention COMPETITOR'S BONE CEMENT| COMPETITOR'S BONE CEMENT