BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 4 CEM

    MDR report key: 7331452 · Received March 12, 2018

    Report

    Report Number
    1818910-2018-54896
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    February 23, 2018
    Report Date
    February 23, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042389
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. 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). 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

    SURGEON: (B)(6), PRODUCT: ATTUNE, COMPLAINT OVERVIEW: LIFTING OF TIBIAL IMPLANT OUT OF THE PREPARED TIBIA DURING FINAL REDUCTION. PATIENT DETAILS: FEMALE, (B)(6), PRE OP OBSERVATIONS: HYPER EXTENSION IN KNEE. TWENTY (20) DEGREE FIXED VALGUS DEFORMITY. DETAILS OF PRODUCT COMPLAINT: EVENT TOOK PLACE WHILE CEMENTING IN FINAL IMPLANTS. KNEE PLACED IN FLEXION TO GAIN ACCESS TO IMPLANT COMPONENTS TIBIA SUBLUXED FORWARD TO ACCESS AND IMPLANT TIBIAL TRAY. ON REDUCTION, THE PREPARED FEMUR WOULD PUT FORCE ON THE POSTERIOR PART OF THE TIBIAL TRAY CAUSING THE TRAY TO LIFT OUT OF THE TIBIAL BONE. TIBIAL COMPONENT DROPPED ON THE FLOOR BY ACCIDENT. NEW TIBIAL COMPONENT OPENED. AN ADDITIONAL ASSISTANT WAS BROUGHT IN TO HELP WITH THE FINAL REDUCTION: ONE ASSISTANT TO PULL TIBIA FORWARD, ONE ASSISTANT TO LIFT FEMUR, SURGEON GUIDED REDUCTION WHILE KEEPING TIBIAL TRAY IN PLACE. FEMORAL COMPONENT IMPLANTED. TIBIAL INSERT TRIAL PLACED IN. KNEE PUT OUT TO EXTENSION TO ALLOW CEMENT TO SET. DEFINITIVE TIBIAL INSERT IMPLANTED. COMPONENT DETAILS: ATTUNE TIBIAL BASE SIZE 4, FIXED BEARING (1506-00-004). LOT: 8678183. (THIS COMPONENT WAS DROPPED AND NOT USED) ATTUNE TIBIAL BASE SIZE 4, FIXED BEARING (1506-00-004). LOT: 8611368. (COMPONENT IMPLANTED)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174917 ATTUNE FB TIB BASE SZ 4 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 8678183 10603295042389

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention