BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY TIBIAL TRAY

    MDR report key: 703392 · Received April 21, 2006

    Report

    Report Number
    1818910-2006-01124
    Event Type
    Injury
    Date Received
    April 21, 2006
    Date of Event
    March 31, 2006
    Report Date
    March 31, 2006
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED, AS THE PRODUCT CODEAND LOT NUMBERS REQ TO REVIEW THE DEVICE HISTORY RECORDS WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY TIBIAL TRAY TOTAL KNEE REPLACEMENT HSH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention