BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY LINER

    MDR report key: 1327404 · Received February 19, 2009

    Report

    Report Number
    1818910-2009-00637
    Event Type
    Injury
    Date Received
    February 19, 2009
    Date of Event
    January 29, 2009
    Report Date
    January 29, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND LOT CODE WAS UNAVAILABLE. ALTHOUGH UNAVAILABLE FOR EVALUATION, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER NEARLY 20 YEARS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ACS CUP AND HEAD REMOVED DUE TO POLY WEAR AND TITANIUM DEBRIS RESULTING FROM WEAR THROUGH OF THE LINER. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY LINER TOTAL HIP PROSTHESIS KWB DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention