BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY FEMORAL COMPONENT

    MDR report key: 1031802 · Received April 17, 2008

    Report

    Report Number
    1818910-2008-01226
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE PRODUCT CODE AND LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WERE NOT PROVIDED. ALTHOUGH INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO, IT WOULD NOT BE UNREASONABLE TO EXPECT SOME WEAR AFTER APPROX 11 YEARS OF IMPLANTATION. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS LOOSENING OF FEMORAL COMPONENT, FOUND OSTEOLYSIS AND POLYETHYLENE WEAR INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY FEMORAL COMPONENT TOTAL KNEE REPLACEMENT HSA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention