BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 7 CEM

    MDR report key: 5754485 · Received June 28, 2016

    Report

    Report Number
    1818910-2016-22293
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    June 20, 2016
    Report Date
    June 20, 2016
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH ON THE PROVIDED ATTUNE FB TIB BASE SZ 7 CEM (PRODUCT CODE 150600007, LOT NUMBER 8010791) FOUND AN ADDITIONAL REPORT. A PREVIOUS DHR REVIEW ((B)(4)) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER. THE PROVIDED EXPLANT PHOTOGRAPH WAS REVIEWED BY COMMERCIALIZED PRODUCT DEVELOPMENT. WITH THE INFORMATION PROVIDED, THE ROOT CAUSE OF POST-OPERATIVE LOOSENING CANNOT BE DEFINITIVELY DETERMINED. (B)(4) HAS BEEN UNDERTAKEN TO INVESTIGATE FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410414 ATTUNE FB TIB BASE SZ 7 CEM KNEE TIBIAL TRAY JWH DEPUY IRELAND ¿ REG. # 9616671 8010791

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention