BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 6 CEM

    MDR report key: 6964764 · Received October 20, 2017

    Report

    Report Number
    1818910-2017-27001
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    November 14, 2016
    Report Date
    November 8, 2019
    Manufacturer
    DEPUY IRELAND 961610 
    Product Code
    JWH
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.  ADDITIONAL NARRATIVE:   UDI:(B)(4). ADDED: (BIRTH DATE), WEIGHT, DESCRIPTION OF EVENT OR PROBLEM, DEVICE IDENTIFICATION (EXPIRATION), REPORT SOURCE AND EVALUATION CODES (PATIENT). CORRECTED: (AGE).

    Description of Event or Problem · 0

    MEDICAL RECORDS ALLEGES ADHESION, JOINT INJURY AND TIBIAL MIGRATION.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. PRODUCT CODE (B)(4), LOT NUMBER 7987262. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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

    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

    COMPLETE PRODUCT DETAIL HAS NOT BEEN RECEIVED AT THIS TIME. IF FURTHER INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. 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. 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. 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

    SEP 21, 2017: LITIGATION RECORD RECEIVED. LITIGATION RECORD RECEIVED SEP 21, 2017. RECORD ALLEGES THE PATIENT RECEIVED AN ATTUNE TOTAL KNEE REPLACEMENT ON (B)(6) 2015. IT ALSO ALLEGES THE PATIENT RECEIVED A PAINFUL REVISION SURGERY ON (B)(6) 2016 DUE TO TIBIAL ASEPTIC LOOSENING. THE DOCUMENT QUOTES THE SURGEON SAYING: ¿THE TIBIAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE AND LIFT FREE FORM THE CEMENT MANTLE WITH VIRTUALLY NO CEMENT ADHERED TO THE TIBIAL IMPLANT.¿ AT THIS TIME THE CEMENT MANUFACTURE IS UNKNOWN. UPDATED 10-20-2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744578 ATTUNE FB TIB BASE SZ 6 CEM KNEE TIBIAL TRAY JWH DEPUY IRELAND 961610  7987262

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention