BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY INSERT

    MDR report key: 1346007 · Received March 16, 2009

    Report

    Report Number
    1818910-2009-01277
    Event Type
    Injury
    Date Received
    March 16, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 2, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED, AS THE PART AND LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. PROVIDED INFORMATION STATES THE PATIENT HAS A HISTORY OF BREAST AND BONE CANCER. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INSTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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 REVISED TO ADDRESS PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention