BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY INSERT

    MDR report key: 1211038 · Received October 23, 2008

    Report

    Report Number
    1818910-2008-04987
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR; HOWEVER, POLYETHYLENE WEAR AFTER 15-YEARS IMPLANTATION SHOULD NOT BE UNEXPECTED. BASED ON THE INVESTIGATION FINDINGS, 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

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY INSERT TOTAL KNEE REPLACEMENT HSH DEPUY ORTHOPAEDICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention