BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV/DOME PAT 3PEG, 41

    MDR report key: 2151313 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11509
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER RELATED REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT; HOWEVER, THE INITIAL REPORTING STATED POOR DEVICE POSITIONING WAS A CONTRIBUTING FACTOR. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED FOR MALALIGNMENT AND LOOSENING OF FEMUR, PATELLA, AND TIBIAL TRAY AT CEMENT/IMPLANT. UNKNOWN MANUFACTURE OF CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/OV/DOME PAT 3PEG, 41 87 JWH JWH DEPUY (IRELAND) NA 2813811

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention