BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DEEP DISH LG 10MM LCS INSERT

    MDR report key: 1600386 · Received February 8, 2010

    Report

    Report Number
    1818910-2010-00312
    Event Type
    Injury
    Date Received
    February 8, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 11, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. THE PRODUCT CODES AND LOT CODES REQUIRED TO SEARCH THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE INFO PROVIDED. PROVIDED INFO POOR DEVICE POSITIONING WAS A CONTRIBUTING FACTOR. IT WAS NOTED THE PRODUCTS WERE IMPLANTED FOR APPROXIMATELY FIFTEEN YEARS PRIOR TO REVISION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS OSTEOLYSIS UNDER FEMORAL COMPONENT, EXCESSIVE POSTERIOR SLOPE OF TIBIAL COMPONENT, AND EXCESSIVELY ROTATED FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY DEEP DISH LG 10MM LCS INSERT TOTAL KNEE PROSTHESIS HSH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention