BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC KEEL TIB TRAY CEM SZ3

    MDR report key: 1063255 · Received June 18, 2008

    Report

    Report Number
    1818910-2008-02198
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, DEPUY-CORK
    Product Code
    JWH
    PMA / PMN Number
    K830927
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL 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. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. PT PHYSICAL STATURE MAY HAVE BEEN A CONTRIBUTING FACTOR. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS LOOSE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC KEEL TIB TRAY CEM SZ3 87JWH JWH DEPUY ORTHOPAEDICS, DEPUY-CORK NA 1906316

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention