BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY MARK II ELBOW

    MDR report key: 2172614 · Received July 19, 2011

    Report

    Report Number
    1818910-2011-13348
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDC
    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 DEVICE AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS UNAVAILABLE. PROVIDED INFO STATES THE BEARING IN THE PRITCHARD MARK 2 ELBOW WORE OUT AFTER 15 YEARS IMPLANTED. THE SURGEON ORDERED A CUSTOM BEARING/PIN REPLACEMENT KIT. REMOVED THE OLD AND INSERTED THE NEW ITEMS WITHOUT INCIDENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE, THE BEARING IN THE ELBOW COMPONENT WORE OUT. OSTEOLYSIS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY MARK II ELBOW TOTAL ELBOW PROSTHESIS JDC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention