BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG MOD TIB TRAY CEM COCR 4

    MDR report key: 1033090 · Received April 22, 2008

    Report

    Report Number
    1818910-2008-01433
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K032151
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MANUFACTURING LOT. THE INITIAL REPORTING INDICATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE EVENT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED DEVICE LOOSENING. 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 ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIG MOD TIB TRAY CEM COCR 4 87JWH JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2217862

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention