BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ4

    MDR report key: 1574879 · Received January 8, 2010

    Report

    Report Number
    1818910-2010-00075
    Event Type
    Injury
    Date Received
    January 8, 2010
    Date of Event
    December 11, 2009
    Report Date
    December 11, 2009
    Manufacturer
    DEPUY-CORK, A DIVISION O F DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S095
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE MFG LOT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE LOOSENING. PROVIDED INFO STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECS OR OF CONTRIBUTING TO THE EVENT. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR PAIN DUE TO LOOSE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM KEEL TIB TRAY SZ4 87NJL NJL DEPUY-CORK, A DIVISION O F DEPUY ORTHOPAEDICS NA 2326978

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention