BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PATELLA

    MDR report key: 1903344 · Received November 16, 2010

    Report

    Report Number
    1818910-2010-08487
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORT EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED TO SEARCH THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSION ABOUT THE REPORTED POLYETHYLENE WEAR BASED ON THE LACK OF THE PRODUCT TO EXAMINE; HOWEVER, POLYETHYLENE WEAR FOR A KNEE DEVICE IMPLANTED FOR APPROX EIGHTEEN YEARS SHOULD NOT BE UNEXPECTED. 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention