BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 5 CEM

    MDR report key: 7167273 · Received January 5, 2018

    Report

    Report Number
    1818910-2018-50285
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    December 6, 2017
    Report Date
    December 6, 2017
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042594
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) 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. 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 GROSS LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER WAS A COMPETITOR. IT WAS ALSO INDICATED THAT THE SURGEON REMOVED ALL COMPONENTS EXCEPT PATELLA 1518-20-038 L- 8182252 AND IMPLANTS RETURNED TO THE PATIENT. NO INSTRUMENTATION BROKE. DOI: (B)(6) 2016; DOR: (B)(6) 2017; RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12846 ATTUNE RP TIB BASE SZ 5 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 8206252 10603295042594

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention