BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG MOD TIB TRAY CEM COCR 5

    MDR report key: 1190376 · Received October 3, 2008

    Report

    Report Number
    1818910-2008-04314
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED, AS THE TIBIAL TRAY REMAINS IMPLANTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT CODE/LOTS PROVIDED SINCE THEIR RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. INFO PROVIDED INDICATES THAT THE PT MAY HAVE HAD AN OLD PLATEAU FRACTURE. IT IS ALSO INDICATED THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    DURING THE CEMENTING OF THE TIBIA, THE TIBIA FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIG MOD TIB TRAY CEM COCR 5 87JWH JWH DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2587682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention