BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRT ULTRA TIB INS SZ4 18MM

    MDR report key: 1214016 · Received October 27, 2008

    Report

    Report Number
    1818910-2008-04924
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K955884
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MANUFACTURING LOT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION OR POLYETHYLENE WEAR; HOWEVER, INFECTION AFTER 10-YEARS IMPLANTATION IS UNLIKELY TO BE PRODUCT RELATED. IN ADDITION, SOME POLYETHYLENE WEAR AFTER 10-YEARS IMPLANTATION SHOULD NOT BE UNEXPECTED. 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 PRODUCTS AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF INFECTION. POLY WEAR OF THE INSERT AND PATELLA NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRT ULTRA TIB INS SZ4 18MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. N/A SN6LP1002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention