BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY PATELLA

    MDR report key: 1033930 · Received April 24, 2008

    Report

    Report Number
    1818910-2008-01152
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 25, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENTS BASED ON THE PROVIDED INFO. BASED ON THE PERFORMED INVESTIGATION, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE PRODUCTS AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    BILATERAL PT CONTACTED DEPUY VIA THE WEBSITE STATING THAT SHE WAS REVISED BECAUSE OF PAIN. MEDICAL RECORDS FROM THE RIGHT KNEE REVISION INDICATE THAT THE PATELLA WAS NOTABLY LOOSE AND EASILY REMOVED. THE PROXIMAL TIBIAL IMPLANTS WAS EASILY REMOVED AND FOUND TO BE LOOSENED IN THE MEDIAL ASPECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention