BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GCK UNI TIB TRAY CEM SZ3 LM/RL

    MDR report key: 1064877 · Received June 23, 2008

    Report

    Report Number
    1818910-2008-02206
    Event Type
    Injury
    Date Received
    June 23, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., DIVISION: DEPUY-RAYNHAM
    Product Code
    HRY
    PMA / PMN Number
    K070267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS NO PRODUCT WAS RETURNED. A SEARCH OF THE INTERNATIONAL COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT/LOTS PROVIDED SINCE THEIR RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. 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

    PATIENT WAS REVISED TO ADDRESS SUBSIDENCE OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCK UNI TIB TRAY CEM SZ3 LM/RL 87HRY & 87NPJ HRY DEPUY ORTHOPAEDICS, INC., DIVISION: DEPUY-RAYNHAM NA B11B44000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention