BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PRESERVATION ALLPOLY TIBIA

    MDR report key: 1201461 · Received October 16, 2008

    Report

    Report Number
    1818910-2008-04654
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO SEARCH THE COMPLAINT DATABASE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT REPORTED EVENT BASED ON THE PROVIDED INFO. BASED ON THE PERFORMED INVESTIGATION, 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, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF COMPLAINTS OF PAIN AND DECREASED RANGE OF MOTION. POLY WEAR OF THE INSERT AND LOOSENING OF THE FEMUR WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PRESERVATION ALLPOLY TIBIA TOTAL KNEE PROSTHESIS HSH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention