BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 5 CEM

    MDR report key: 6051805 · Received October 24, 2016

    Report

    Report Number
    1818910-2016-30047
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. (B)(4) HAS BEEN UNDERTAKEN TO INVESTIGATE FURTHER. THE ANALYSES AND INVESTIGATIONS EVENTUALLY LED TO A NEW PRODUCT DEVELOPMENT PROJECT, WHICH WILL ENHANCE FIXATION AND MAKE THE PRODUCT MORE ROBUST TO SURGICAL TECHNIQUE PER CO (B)(4). 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

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (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

    PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703398 ATTUNE RP TIB BASE SZ 5 CEM KNEE TIBIAL TRAY NJL DEPUY IRELAND 9616671 8272660

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention