BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG MOD TIB TRAY CEM COCR 4

    MDR report key: 3832175 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-19445
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    DEPUY IRELAND REG. # 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK032151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INITIAL REPORTING STATED NO INVESTIGATIONAL INPUTS WERE AVAILABLE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT BASED ON THE AVAILABLE INFORMATION. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT REVISION DUE TO PAIN AND LOOSENING. THE SURGEON REVISED THE TIBIAL COMPONENT, FEMORAL COMPONENT AND THE TIBIAL INSERT. THE PATELLA REMAINED IN SITU. PRODUCT CODES AND LOT NUMBERS TO BE ADVISED, PRIMARY PROCEDURE DATE AND HOSPITAL TO BE ADVISED. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310766 SIG MOD TIB TRAY CEM COCR 4 KNEE TIBIAL TRAY JWH DEPUY IRELAND REG. # 9616671 3130750

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention