BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY FEMORAL

    MDR report key: 1000394 · Received February 19, 2008

    Report

    Report Number
    1818910-2008-00385
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNK, IT WAS REPORTED TO HAVE OCCURRED APPROX 2-3 YRS AGO. EVAL WAS NOT POSSIBLE, AS THE PROD WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE PROD CODE AND LOT #S REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WERE NOT PROVIDED. ALTHOUGH THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO, THE INITIAL REPORT INDICATES THAT POOR BONE QUALITY MAY HAVE BEEN A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention