BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY STD+ PATELLA POLY

    MDR report key: 2864692 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-83332
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE; HOWEVER, WEAR OF A POLYETHYLENE DEVICE AFTER BEING IMPLANTED FOR APPROXIMATELY TWENTY-YEARS SHOULD NOT BE UNEXPECTED. INFECTION AFTER THE REPORTED PERIOD OF TIME IS UNLIKELY TO BE PRODUCT RELATED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION AND POLY WEAR OF THE MESCAL BEARINGS AND PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY STD+ PATELLA POLY PATELLA PROSTHESIS HTG DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention